Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

Wyeth is now a wholly owned subsidiary of Pfizer708 enrolled

Overview

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

708

Conditions

Pneumococcal Infections

Interventions

13-valent Pneumococcal Conjugate VaccineBIOLOGICAL

1 dose at 6, 10, 14 weeks and 12 months of age

7 valent pneumococcal conjugate vaccineBIOLOGICAL

1 dose at 6, 10, 14 weeks and 12 months of age

Eligibility

Sex: ALLMin age: 42 DaysMax age: 72 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. Healthy infants aged 6 weeks (42-72 days) at time of enrolment 2. Available for the entire study period Exclusion Criteria 1. Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines 2. A previous anaphylactic reaction to any vaccine or vaccine-related component 3. Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines

Locations (12)

Unnamed facility

Sector-12, Chandigarh, India

Unnamed facility

Sector-32 B, Chandigarh, India

Unnamed facility

Bangalore, Karnataka, India

Unnamed facility

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.

Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% 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 19 A) are presented.

Time frame: 1 month after the infant series (18 weeks of age)

Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.

Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay \[ELISA\] units per mL \[EU/mL\]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.

Time frame: 1 month after the infant series (18 weeks of age)

Secondary Outcomes

Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.

Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact, 2-sided 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 19 A) are presented.

Time frame: 1 month after the toddler dose (13 months of age)

Data from ClinicalTrials.gov

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