Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

Phase 3

Completed

• Conditions: Vaccines; Pneumococcal Conjugate Vaccine
• Interventions: Biological: 7-valent pneumococcal conjugate vaccine (7vPnC); Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

• Registration Number: NCT00688870
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Study Start: 2008-06-05
• Primary Completion: 2010-01-13
• Study Completion: 2010-01-13
• Results First Submitted: 2011-01-13
• Results First Submitted QC: 2011-04-18
• Results First Posted: 2011-05-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Healthy 2-month-old infants (42 to 98 days)
• Available for the entire study period (14 months)

Exclusion Criteria

• Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
• A previous anaphylactic reaction to any vaccine or vaccine-related component.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	7-valent pneumococcal conjugate vaccine (7vPnC)	7vPnC
1	13-valent pneumococcal conjugate vaccine (13vPnC)	13vPnC

Primary Outcome Measures

Name	Time	Method
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.	1 month after the infant series (7 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 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 19A) are presented.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 mcg/mL, 1 Month After the Toddler Dose	1 month after toddler dose (16 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 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.

Trial Locations

Locations (2)

Chang Gung Memorial Hospital - Linko; 🇨🇳 Taoyuan Hsien, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan