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

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
13-valent Pneumococcal Conjugate Vaccine
7 valent pneumococcal conjugate vaccine
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Vaccines, Pneumococcal

Eligibility Criteria

42 Days - 72 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 23, 2007
Last Updated
March 22, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00452790
Brief Title
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
Vaccines, Pneumococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
708 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
13-valent Pneumococcal Conjugate Vaccine
Intervention Description
1 dose at 6, 10, 14 weeks and 12 months of age
Intervention Type
Biological
Intervention Name(s)
7 valent pneumococcal conjugate vaccine
Intervention Description
1 dose at 6, 10, 14 weeks and 12 months of age
Primary Outcome Measure Information:
Title
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.
Description
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)
Title
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.
Description
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 Outcome Measure Information:
Title
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
Description
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)
Other Pre-specified Outcome Measures:
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
Description
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.
Time Frame
1 month after the 3-dose infant series (18 weeks of age)
Title
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
Description
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.
Time Frame
1 month after toddler dose (13 months of age)
Title
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Description
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.
Time Frame
Within 4 days after the dose 1 of the infant series (6 weeks of age)
Title
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (10 Weeks of Age)
Description
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.
Time Frame
Within 4 days after the dose 2 of the infant series (10 weeks of age)
Title
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (14 Weeks of Age)
Description
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.
Time Frame
Within 4 days after the dose 3 of the infant series (14 weeks of age)
Title
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
Description
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.
Time Frame
Within 4 days after the toddler dose (12 months of age)
Title
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (6 Weeks of Age)
Description
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.
Time Frame
Within 4 days after the dose 1 of the infant series (6 weeks of age)
Title
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (10 Weeks of Age)
Description
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.
Time Frame
Within 4 days after the dose 2 of the infant series (10 weeks of age)
Title
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (14 Weeks of Age)
Description
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.
Time Frame
Within 4 days after the dose 3 of the infant series (14 weeks of age)
Title
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
Description
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.
Time Frame
Within 4 days after the toddler dose(12 months of age)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
72 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Healthy infants aged 6 weeks (42-72 days) at time of enrolment Available for the entire study period Exclusion Criteria Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines A previous anaphylactic reaction to any vaccine or vaccine-related component Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Sector-12
State/Province
Chandigarh
ZIP/Postal Code
160 012
Country
India
City
Sector-32 B
State/Province
Chandigarh
ZIP/Postal Code
160031
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560017
Country
India
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 026
Country
India
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 043
Country
India
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
City
Rajinder Nagar
State/Province
New Delhi
ZIP/Postal Code
110 060
Country
India
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600034
Country
India
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632 004
Country
India

12. IPD Sharing Statement

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

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