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

March 22, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

708

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chandigarh
      • Sector-12, Chandigarh, India, 160 012
      • Sector-32 B, Chandigarh, India, 160031
    • Karnataka
      • Bangalore, Karnataka, India, 560017
      • Bangalore, Karnataka, India, 560 034
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 026
      • Pune, Maharashtra, India, 411001
      • Pune, Maharashtra, India, 411011
      • Pune, Maharashtra, India, 411 043
    • New Delhi
      • Rajinder Nagar, New Delhi, India, 110 060
    • Punjab
      • Ludhiana, Punjab, India, 141008
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600034
      • Vellore, Tamil Nadu, India, 632 004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Biological: 7 valent pneumococcal conjugate vaccine
1 dose at 6, 10, 14 weeks and 12 months of age
Experimental: A
Biological: 13-valent Pneumococcal Conjugate Vaccine
1 dose at 6, 10, 14 weeks and 12 months of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 month after the infant series (18 weeks of age)
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.
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.
Time Frame: 1 month after the infant series (18 weeks of age)
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.
1 month after the infant series (18 weeks of age)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Time Frame: 1 month after the toddler dose (13 months of age)
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.
1 month after the toddler dose (13 months of age)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Time Frame: 1 month after the 3-dose infant series (18 weeks of age)
Antibody GMC as measured in mcg/mL 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. GMC (13vPnC) and corresponding O'Brien-Fleming-adjusted, 2-sided 95% CIs were calculated.
1 month after the 3-dose infant series (18 weeks of age)
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Time Frame: 1 month after toddler dose (13 months of age)
Antibody GMC as measured in mcg/mL 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. GMC (13vPnC) and corresponding 2-sided 95% CIs were presented.
1 month after toddler dose (13 months of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Time Frame: Within 4 days after the dose 1 of the infant series (6 weeks of age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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.
Within 4 days after the dose 1 of the infant series (6 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Time Frame: Within 4 days after the dose 2 of the infant series (10 weeks of age)
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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.
Within 4 days after the dose 2 of the infant series (10 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Time Frame: Within 4 days after the dose 3 of the infant series (14 weeks of age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 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.
Within 4 days after the dose 3 of the infant series (14 weeks of age)
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Time Frame: Within 4 days after the toddler dose (12 months of age)
Local reactions were reported using an electronic diary by the parent/legal guardian. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration and erythema present); Mild (0.5 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.
Within 4 days after the toddler dose (12 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Time Frame: Within 4 days after the dose 1 of the infant series (6 weeks of age)
Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after the dose 1 of the infant series (6 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Time Frame: Within 4 days after the dose 2 of the infant series (10 weeks of age)
Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after the dose 2 of the infant series (10 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Time Frame: Within 4 days after the dose 3 of the infant series (14 weeks of age)
Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after the dose 3 of the infant series (14 weeks of age)
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Time Frame: Within 4 days after the toddler dose(12 months of age)
Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Within 4 days after the toddler dose(12 months of age)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 23, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (Estimate)

March 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 22, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6096A1-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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