Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

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 50 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

44 sites in 1 country.

About this study

Official title: A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.

Conditions

PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE

Being tested

13-valent pneumococcal conjugate vaccine, Seasonal Inactivated Influenza Vaccine, Placebo

Keywords

Pneumococcal polysaccharide vaccine, 13-valent pneumococcal conjugate vaccine, invasive pneumococcal disease, flu vaccine

Medical subject headings

Influenza, Human

What participants receive

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

• 13-valent pneumococcal conjugate vaccineBiological

  Also called 13vPnC

  One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

• Seasonal Inactivated Influenza VaccineBiological

  Also called SIIV

  One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.

• PlaceboOther

  One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

• PlaceboOther

  One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

• Seasonal Inactivated Influenza VaccineBiological

  Also called SIIV

  One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.

• 13-valent pneumococcal conjugate vaccineBiological

  Also called 13vPnC

  One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

What is being measured

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

1. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes

   Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with a determinate OPA titer to the given serotype.

   Measured: 1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC

2. Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)

   HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies participants with a determinate HAI titer to the given strain.

   Measured: 1 month after Vaccination 1

3. Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1

   An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

   Measured: Within 28 to 42 days after Vaccination 1

4. Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2

   An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

   Measured: Within 28 to 42 days after Vaccination 2

5. Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination

   An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

   Measured: Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2

6. Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up

   An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).

   Measured: Within 168 to 196 days after Vaccination 2

Timeline

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

1. First posted28 Apr 2014 (estimated)
2. Study startSep 2014
3. Primary completionMay 2015
4. Study completionMay 2015

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.
• Other trials for PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASEStudies 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.