13-valent Pneumococcal VaccinePhase 4NCT01193335

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

A Phase 4 study testing 13-valent pneumococcal conjugate vaccine in people with 13-valent Pneumococcal Vaccine and Premature Birth, run by Pfizer at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of… Read more about this study

Who is it for?: Ages 42 to 98 days
Conditions the study is for: 13-valent Pneumococcal Vaccine, Premature Birth, Immunization
What is being tested?: 13-valent pneumococcal conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 12 sitesin 2 countries
Study dates: Oct 2010to Jan 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 42 to 98 days
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.

Who cannot join

Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
Previous anaphylactic reaction or allergy to any vaccine
Contraindication to vaccination
Known or suspected immune deficiency or immune suppression
Major known congenital malformation or serious chronic disorder
Significant neurological disorder
Participation to another study

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

Poland6 sites

NZOZ "HIPOKRATES-II" Sp. z o.o.
Krakow, 31-223
Hanna Czajka Indywidualna Praktyka Specjalistyczna Lekarska
Krakow, 31-302
SP ZOZ Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego w Lodzi
Lodz, 91-347
Specjalistyczny ZOZ nad Matka i Dzieckiem
Poznan, 61-825
Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
Trzebnica, 55-100
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, 50-345

Other trials in Poland

Spain6 sites

Complejo Hospitalario DE Torrecardenas
Almería, Almeria, 04009
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario de La Paz
Madrid, 28046
Complejo Hospitalario de Navarra
Pamplona, 31008
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Complexo Hospitalario Xeral Cies
Vigo, Pontevedra, 36204

Other trials in Spain

About this study

Official title: A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants

Conditions: 13-valent Pneumococcal Vaccine, Premature Birth, Immunization, Safety
Being tested: 13-valent pneumococcal conjugate vaccine
Keywords: 13-valent pneumococcal conjugate vaccine, premature, immunization, safety.
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

13-valent pneumococcal conjugate vaccineBiological
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
13-valent pneumococcal conjugate vaccineBiological
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.

Study groups in NCT01193335
Study group	Role	What they receive
Group 1: Preterm infants	Active comparator	Infant born at < 37 weeks of gestation. Receives: Biological: 13-valent pneumococcal conjugate vaccine
Group 2: Term infants	Active comparator	Infants born at ≥ 37 weeks of gestation Receives: Biological: 13-valent pneumococcal conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Measured: 1 month after the infant series
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Measured: 1 month after the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 7 days after Dose 1 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 7 days after Dose 2 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 7 days after Dose 3 of the infant series
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 7 days after the toddler dose
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Measured: Within 7 days after Dose 1 of the infant series
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Measured: Within 7 days after Dose 2 of the infant series
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Measured: Within 7 days after Dose 3 of the infant series
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Measured: Within 7 days after the toddler dose
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Dose 1 up to 1 month after Dose 3 (infant series)
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: 1 Month after Dose 3 of the infant series up to toddler dose
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Toddler dose up to 1 Month after toddler dose
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: 1 month after toddler dose up to 1-year follow-up
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: 1-year follow-up after toddler dose to 2-year follow-up after toddler dose

Secondary outcomes (23)

Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws.
Measured: Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Measured: 1 Month After Infant Series
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
Measured: 1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 month after the toddler dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Measured: Before Toddler Dose (pre-vaccination)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Measured: 1 Month After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Measured: 1 Year After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Measured: 2 Years After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Measured: 1 Month After Infant Series
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Measured: Before Toddler Dose (pre-vaccination)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Measured: 1 Month After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Measured: 1 Year After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Measured: 2 Years After Toddler Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Measured: 1 Month After Infant Series
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Measured: Before the toddler dose (pre-vaccination)
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Measured: 1 Month After Toddler Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Measured: 1 Year After Toddler Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Measured: 2 Years After Toddler Dose
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Measured: 1 Month After Infant Series
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Measured: Before Toddler Dose (pre-vaccination)
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Measured: 1 Month After Toddler Dose
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Measured: 1 Year After Toddler Dose
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.
Measured: 2 Years After Toddler Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Jan 2014

First posted1 Sep 2010 (estimated)
Study startOct 2010
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 13-valent Pneumococcal VaccineStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193335
Sponsor's protocol ID: B1851037
Other IDs: 6096A1-4001, 2009-017332-41, 2009
Status last verified: Sep 2016
First submitted: 31 Aug 2010
Last updated: 11 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Martinon-Torres F, Wysocki J, Center KJ, Czajka H, Majda-Stanislawska E, Omenaca F, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Blazquez-Gamero D, Moreno-Galarraga L, Giardina PC, Sun G, Gruber WC, Scott DA, Gurtman A. Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared With Term Infants. Pediatr Infect Dis J. 2017 Mar;36(3):326-332. doi: 10.1097/INF.0000000000001428.
PubMed 27902652
Martinon-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omenaca F, Bernaola Iturbe E, Blazquez Gamero D, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Giardina PC, Patterson S, Gruber WC, Scott DA, Gurtman A. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr;135(4):e876-86. doi: 10.1542/peds.2014-2941. Epub 2015 Mar 16.
PubMed 25780077

Want to know more?

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Questions to ask the study team

What is the study trying to find out?
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What happens when the study ends?

See locations

Active, not recruitingPhase 2
Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy
Diffuse Large-Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
Not yet recruitingPhase 3
A Lot-to-Lot Consistency Clinical Trial of PCV13
Pneumococcal Infectious Diseases
Not yet recruitingObservational study
A Clinical Trial of the 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
Pneumococcal Infections, Streptococcal Infections
Active, not recruitingPhase 3
A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infants Aged 2 Months (Minimum 6 Weeks)
Pneumococcal Infections, Streptococcal Infections
Not yet recruitingPhase 3
Clinical Trial of PCV13 in Infants Aged Approximately 2 Months (42 to 89 Days)
Pneumococcal Infectious Diseases

All 13-valent Pneumococcal Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants
ClinicalTrials.gov ID: NCT01193335
Acronym / sponsor ID: B1851037
Conditions: 13-valent Pneumococcal Vaccine, Premature Birth, Immunization, Safety
Keywords: 13-valent pneumococcal conjugate vaccine, premature, immunization, safety.
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 1 Sep 2010 (estimated)
Results: Posted 4 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: Preterm infants	Active comparator	Biological: 13-valent pneumococcal conjugate vaccineInfant born at < 37 weeks of gestation.
Group 2: Term infants	Active comparator	Biological: 13-valent pneumococcal conjugate vaccineInfants born at ≥ 37 weeks of gestation

Who may qualify

Ages: 42 to 98 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.

Key exclusion criteria (7 listed)

Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
Previous anaphylactic reaction or allergy to any vaccine
Contraindication to vaccination
Known or suspected immune deficiency or immune suppression
Major known congenital malformation or serious chronic disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
13-valent pneumococcal conjugate vaccine13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.	Biological	Group 1: Preterm infants
13-valent pneumococcal conjugate vaccine13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.	Biological	Group 2: Term infants

Primary outcome

Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series
Time frame: 1 month after the infant series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Time frame: 1 month after the infant series
Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
Time frame: Within 7 days after Dose 1 of the infant series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
Time frame: Within 7 days after Dose 2 of the infant series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
Time frame: Within 7 days after Dose 3 of the infant series
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
Time frame: Within 7 days after the toddler dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
Time frame: Within 7 days after Dose 1 of the infant series
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
Time frame: Within 7 days after Dose 2 of the infant series
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
Time frame: Within 7 days after Dose 3 of the infant series
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
Time frame: Within 7 days after the toddler dose
Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series
Time frame: Dose 1 up to 1 month after Dose 3 (infant series)
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series
Time frame: 1 Month after Dose 3 of the infant series up to toddler dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose
Time frame: Toddler dose up to 1 Month after toddler dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose
Time frame: 1 month after toddler dose up to 1-year follow-up
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose
Time frame: 1-year follow-up after toddler dose to 2-year follow-up after toddler dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

23 secondary outcomes

Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
Time frame: Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
Time frame: 1 Month After Infant Series
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
Time frame: 1 month after the toddler dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
Time frame: Before Toddler Dose (pre-vaccination)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
Time frame: 1 Month After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
Time frame: 1 Year After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
Time frame: 2 Years After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
Time frame: 1 Month After Infant Series
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
Time frame: Before Toddler Dose (pre-vaccination)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
Time frame: 1 Month After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
Time frame: 1 Year After Toddler Dose
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
Time frame: 2 Years After Toddler Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
Time frame: 1 Month After Infant Series
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
Time frame: Before the toddler dose (pre-vaccination)
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
Time frame: 1 Month After Toddler Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
Time frame: 1 Year After Toddler Dose
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
Time frame: 2 Years After Toddler Dose
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Time frame: 1 Month After Infant Series
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
Time frame: Before Toddler Dose (pre-vaccination)
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
Time frame: 1 Month After Toddler Dose
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
Time frame: 1 Year After Toddler Dose
Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
Time frame: 2 Years After Toddler Dose

Results and safety

Results posted to the registry on 4 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC Group 1 (Preterm Infant)	100	100
13vPnC Group 2 (Term Infant)	100	100

Primary outcome: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series

Time frame: 1 month after the infant series. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC Group 1 (Preterm Infant) n = 99	13vPnC Group 2 (Term Infant) n = 98
4 (n=99, 97)	96.97 (91.40 to 99.37)	98.97 (94.39 to 99.97)
6B (n=99, 97)	72.73 (62.85 to 81.20)	87.63 (79.39 to 93.44)
9V (n=99, 97)	96.97 (91.40 to 99.37)	96.91 (91.23 to 99.36)
14 (n=99, 97)	100.00 (96.34 to 100.00)	97.94 (92.75 to 99.75)
18C (n=99, 97)	96.97 (91.40 to 99.37)	94.85 (88.38 to 98.31)
19F (n=99, 97)	98.99 (94.50 to 99.97)	98.97 (94.39 to 99.97)
23F (n=99, 97 )	85.86 (77.41 to 92.05)	92.78 (85.70 to 97.05)
1 (n=99, 97)	93.94 (87.27 to 97.74)	95.88 (89.78 to 98.87)

13vPnC Group 1 (Preterm Infant) vs 13vPnC Group 2 (Term Infant): Percent difference: -2.00 (95% CI -7.65 to 2.88)
13vPnC Group 1 (Preterm Infant) vs 13vPnC Group 2 (Term Infant): Percent difference: -14.90 (95% CI -26.40 to -3.21)
13vPnC Group 1 (Preterm Infant) vs 13vPnC Group 2 (Term Infant): Percent difference: 0.06 (95% CI -5.84 to 6.05)

Population analysed: Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Primary outcome: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

Time frame: 1 month after the infant series. Geometric mean (95% Confidence Interval). Unit: mcg/mL

Measure	13vPnC Group 1 (Preterm Infant) n = 99	13vPnC Group 2 (Term Infant) n = 98
4 (n=99, 97)	1.96 (1.67 to 2.31)	2.46 (2.04 to 2.97)
6B (n=99, 97)	0.73 (0.55 to 0.97)	1.30 (1.00 to 1.67)
9V (n=99, 97)	1.26 (1.08 to 1.47)	1.70 (1.45 to 2.00)
14 (n=99, 97)	7.48 (6.23 to 8.99)	6.08 (4.82 to 7.67)
18C (n=99, 97)	1.93 (1.66 to 2.24)	1.93 (1.62 to 2.29)
19F (n=99, 97)	2.21 (1.89 to 2.58)	3.05 (2.62 to 3.55)
23F (n=99, 97)	0.86 (0.69 to 1.07)	1.36 (1.10 to 1.68)
1 (n=99, 97)	1.26 (1.06 to 1.48)	1.79 (1.50 to 2.13)

13vPnC Group 1 (Preterm Infant) vs 13vPnC Group 2 (Term Infant): GMC ratio: 0.80 (95% CI 0.62 to 1.02)
13vPnC Group 1 (Preterm Infant) vs 13vPnC Group 2 (Term Infant): GMC ratio: 0.56 (95% CI 0.38 to 0.82)
13vPnC Group 1 (Preterm Infant) vs 13vPnC Group 2 (Term Infant): GMC ratio: 0.74 (95% CI 0.59 to 0.93)

Population analysed: Evaluable infant immunogenicity population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.

Primary outcome: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series

Time frame: Within 7 days after Dose 1 of the infant series. Number. Unit: percentage of participants

Measure	13vPnC Group 1 (Preterm Infant) n = 98	13vPnC Group 2 (Term Infant) n = 92
Tenderness- Any (n=94, 88)	48.9	42.0
Tenderness- Mild (n=93, 88)	46.2	31.8
Tenderness- Moderate (n=90, 85)	17.8	16.5
Tenderness- Severe (n=86, 85)	0.0	0.0
Swelling- Any (n=94, 89)	39.4	29.2
Swelling- Mild (n=91, 89)	37.4	28.1
Swelling- Moderate (n=91, 85)	8.8	8.2
Swelling- Severe (n=86, 85)	0.0	0.0

Population analysed: Safety population for Dose 1 infant series: all participants who received13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

Primary outcome: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series

Time frame: Within 7 days after Dose 2 of the infant series. Number. Unit: percentage of participants

Measure	13vPnC Group 1 (Preterm Infant) n = 89	13vPnC Group 2 (Term Infant) n = 89
Tenderness- Any (n=85, 88 )	48.2	38.6
Tenderness- Mild (n=85, 84)	43.5	31.0
Tenderness- Moderate (n=77, 83)	14.3	15.7
Tenderness- Severe (n=73, 77)	0.0	1.3
Swelling- Any (n=84, 82)	35.7	42.7
Swelling- Mild (n=83, 82)	33.7	42.7
Swelling- Moderate (n=75, 76)	8.0	2.6
Swelling- Severe (n=73, 76)	0.0	0.0

Population analysed: Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Participants recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Group 1 (Preterm Infant) - Infant Series	14 of 100 (14%)	98 of 100 (98%)	Not reported
13vPnC Group 2 (Term Infant) - Infant Series	5 of 100 (5%)	99 of 100 (99%)	Not reported
13vPnC Group 1 (Preterm Infant) - After Infant Series	8 of 100 (8%)	13 of 100 (13%)	Not reported
13vPnC Group 2 (Term Infant) - After Infant Series	9 of 100 (9%)	11 of 100 (11%)	Not reported
13vPnC Group 1 (Preterm Infant) - Toddler Dose	2 of 99 (2%)	93 of 99 (93.9%)	Not reported
13vPnC Group 2 (Term Infant) - Toddler Dose	1 of 97 (1%)	92 of 97 (94.8%)	Not reported
13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up	13 of 99 (13.1%)	2 of 99 (2%)	Not reported
13vPnC Group 2 (Term Infant) - 1 Year Follow-up	8 of 97 (8.2%)	0 of 97 (0%)	Not reported
13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up	6 of 88 (6.8%)	1 of 88 (1.1%)	Not reported
13vPnC Group 2 (Term Infant) - 2 Year Follow-up	8 of 88 (9.1%)	1 of 88 (1.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27902652Martinon-Torres F, Wysocki J, Center KJ, Czajka H, Majda-Stanislawska E, Omenaca F, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Blazquez-Gamero D, Moreno-Galarraga L, Giardina PC, Sun G, Gruber WC, Scott DA, Gurtman A. Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared With Term Infants. Pediatr Infect Dis J. 2017 Mar;36(3):326-332. doi: 10.1097/INF.0000000000001428.
Derived from this study: PubMed 25780077Martinon-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omenaca F, Bernaola Iturbe E, Blazquez Gamero D, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Giardina PC, Patterson S, Gruber WC, Scott DA, Gurtman A. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr;135(4):e876-86. doi: 10.1542/peds.2014-2941. Epub 2015 Mar 16.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 13-valent pneumococcal conjugate vaccine in people with 13-valent Pneumococcal Vaccine and Premature Birth, run by Pfizer at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series (time frame: 1 month after the infant series). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01193335, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.