Vaccines, PneumococcalPhase 3NCT00366548

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

A Phase 3 study testing 13 valent pneumococcal conjugate vaccine with Polysorbate 80 and 13 valent pneumococcal conjugate vaccine without Polysorbate 80 in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 14 sites in Poland.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric… Read more about this study

Who is it for?: Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal
What is being tested?: 13 valent pneumococcal conjugate vaccine with Polysorbate 80 and 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 14 sitesPoland
Study dates: Nov 2006to Jun 2008
Phase: Phase 3
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
Healthy volunteers accepted
Child

Who may be able to join

Aged 2 months (42 through 98 days) at the time of enrollment.
Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
In good health as determined by medical history, physical examination, and judgment of the investigator.
Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.

Show all 10Show fewer

History of culture-proven invasive disease caused by S pneumoniae.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Poland14 sites

Study site
Bydgoszcz, 85-168
Study site
Dębica, 39-200
Study site
Krakow, 30-663
Study site
Krakow, 31-202
Study site
Krakow, 31-422
Study site
Lodz, 91-347
Study site
Lubartów, 21-100
Study site
Lublin, 20-044
Study site
Oborniki Śląskie, 55-120
Study site
Poznan, 60-535
Study site
Poznan, 61-709
Study site
Siemianowice Śląskie, 41-103
Study site
Torun, 87-100
Study site
Trzebnica, 55-100

Other trials in Poland

About this study

Official title: A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

Conditions: Vaccines, Pneumococcal
Being tested: 13 valent pneumococcal conjugate vaccine with Polysorbate 80, 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Keywords: Vaccine, Infant

What participants receive

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

13 valent pneumococcal conjugate vaccine with Polysorbate 80Biological
13 valent pneumococcal conjugate vaccine without Polysorbate 80Biological

Study groups in NCT00366548
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
2	Active comparator	Not described Receives: Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

What is being measured

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

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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) are presented.
Measured: One month after 3-dose infant series (at 5 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented.
Measured: One month after 3-dose infant series (at 5 months of age)

Secondary outcomes (2)

Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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) are presented.
Measured: one month after the toddler dose (at 13 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented.
Measured: one month after the toddler dose (at 13 months of age)

Timeline

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

Nov 2006Jun 2008

First posted21 Aug 2006 (estimated)
Study startNov 2006
Primary completionJun 2008
Study completionJun 2008

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 (1)Papers the sponsor has linked to this study.
Other trials for Vaccines, PneumococcalStudies of the same condition, open and under way.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00366548
Sponsor's protocol ID: 6096A1-009
Status last verified: Jul 2012
First submitted: 17 Aug 2006
Last updated: 15 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.
PubMed 25126854

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

All Vaccines, Pneumococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations
ClinicalTrials.gov ID: NCT00366548
Acronym / sponsor ID: 6096A1-009
Conditions: Vaccines, Pneumococcal
Keywords: Vaccine, Infant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 21 Aug 2006 (estimated)
Results: Posted 15 Aug 2012

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: Double blind
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
2	Active comparator	Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

Who may qualify

Ages: 42 to 98 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Aged 2 months (42 through 98 days) at the time of enrollment.
Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
In good health as determined by medical history, physical examination, and judgment of the investigator.
Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.

Key exclusion criteria (10 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

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 vaccine with Polysorbate 80	Biological	1
13 valent pneumococcal conjugate vaccine without Polysorbate 80	Biological	2

Primary outcome

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
Time frame: One month after 3-dose infant series (at 5 months of age)
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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) are presented.
Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
Time frame: One month after 3-dose infant series (at 5 months of age)
GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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) are presented.

2 secondary outcomes

Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose
Time frame: one month after the toddler dose (at 13 months of age)
Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
Time frame: one month after the toddler dose (at 13 months of age)

Results and safety

Results posted to the registry on 15 Aug 2012, 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 With (+) Polysorbate 80	250	246
13vPnC Without (-) Polysorbate 80	250	245

Primary outcome: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series

Time frame: One month after 3-dose infant series (at 5 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC + Polysorbate 80 After the Infant Series n = 238	13vPnC - Polysorbate 80 After the Infant Series n = 238
Common Serotypes - Serotype 4 (n=222,224)	93.3 (89.3 to 96.1)	94.1 (90.3 to 96.7)
Common Serotypes - Serotype 6B (n=145,158)	60.9 (54.4 to 67.2)	66.4 (60.0 to 72.4)
Common Serotypes - Serotype 9V (n=231,232)	97.1 (94.0 to 98.8)	97.5 (94.6 to 99.1)
Common Serotypes - Serotype 14 (n=225,232)	94.5 (90.8 to 97.1)	97.5 (94.6 to 99.1)
Common Serotypes - Serotype 18C (n=233,233)	97.9 (95.2 to 99.3)	97.9 (95.2 to 99.3)
Common Serotypes - Serotype 19F (n=228,234)	95.8 (92.4 to 98.0)	98.3 (95.8 to 99.5)
Common Serotypes - Serotype 23F (n=205,220)	86.1 (81.1 to 90.3)	92.4 (88.3 to 95.5)
Additional Serotypes - Serotype 1 (n=228,220)	95.8 (92.4 to 98.0)	92.4 (88.3 to 95.5)

13vPnC + Polysorbate 80 After the Infant Series vs 13vPnC - Polysorbate 80 After the Infant Series: Difference: -0.8 (95% CI -5.4 to 3.7)
13vPnC + Polysorbate 80 After the Infant Series vs 13vPnC - Polysorbate 80 After the Infant Series: Difference: -5.5 (95% CI -14.2 to 3.3)
13vPnC + Polysorbate 80 After the Infant Series vs 13vPnC - Polysorbate 80 After the Infant Series: Difference: -0.4 (95% CI -3.7 to 2.8)

Population analysed: Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype.

Primary outcome: Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series

Time frame: One month after 3-dose infant series (at 5 months of age). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	13vPnC + Polysorbate 80 After the Infant Series n = 238	13vPnC - Polysorbate 80 After the Infant Series n = 238
Common Serotypes - Serotype 4	1.47 (1.30 to 1.65)	1.53 (1.36 to 1.72)
Common Serotypes - Serotype 6B	0.51 (0.44 to 0.60)	0.57 (0.48 to 0.68)
Common Serotypes - Serotype 9V	1.46 (1.34 to 1.60)	1.51 (1.38 to 1.65)
Common Serotypes - Serotype 14	2.37 (2.06 to 2.73)	2.48 (2.20 to 2.80)
Common Serotypes - Serotype 18C	1.84 (1.67 to 2.03)	1.87 (1.71 to 2.04)
Common Serotypes - Serotype 19F	1.46 (1.30 to 1.65)	1.75 (1.60 to 1.91)
Common Serotypes - Serotype 23F	0.93 (0.83 to 1.05)	1.11 (1.00 to 1.24)
Additional Serotypes - Serotype 1	1.39 (1.26 to 1.55)	1.48 (1.32 to 1.66)

13vPnC + Polysorbate 80 After the Infant Series vs 13vPnC - Polysorbate 80 After the Infant Series: Difference: 0.96 (95% CI 0.81 to 1.13)
13vPnC + Polysorbate 80 After the Infant Series vs 13vPnC - Polysorbate 80 After the Infant Series: Difference: 0.90 (95% CI 0.72 to 1.14)
13vPnC + Polysorbate 80 After the Infant Series vs 13vPnC - Polysorbate 80 After the Infant Series: Difference: 0.97 (95% CI 0.85 to 1.10)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC + P80 Infant Series	15 of 249 (6%)	132 of 249 (53%)	Not reported
13vPnC - P 80 Infant Series	21 of 250 (8.4%)	132 of 250 (52.8%)	Not reported
13vPnC + P80 Post-Infant Series	24 of 249 (9.6%)	15 of 249 (6%)	Not reported
13vPnC - P80 Post-Infant Series	16 of 250 (6.4%)	9 of 250 (3.6%)	Not reported
13vPnC + P80 Toddler Dose	3 of 239 (1.3%)	91 of 239 (38.1%)	Not reported
13vPnC - P80 Toddler Dose	2 of 244 (0.8%)	111 of 244 (45.5%)	Not reported
13vPnC + P80 6-Month Follow-up	13 of 249 (5.2%)	0 of 249 (0%)	Not reported
13vPnC - P80 6-Month Follow-up	14 of 250 (5.6%)	1 of 250 (0.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25126854Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.

Related trials for Vaccines, Pneumococcal

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

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.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager principal investigator

For Poland, WPWZMED@wyeth.com

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 10 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Poland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Aug 2012). 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 Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series (time frame: One month after 3-dose infant series (at 5 months of age)). The study lists 2 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 NCT00366548, which also lists 1 linked publication.

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 15 Aug 2012.