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

NCT00688870 | Completed Phase 3 Results

• 3 other identifiers: 6096A1-3004B18510052008-004766-40
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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.

Conditions

Vaccines; Pneumococcal Conjugate Vaccine

Keywords

Prevention against pneumococcal disease

Outcome Measures

Primary Outcomes (1)

• 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 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.

  1 month after the infant series (7 months of age)

Secondary Outcomes (1)

• 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)

Other Outcomes (10)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series

  1 month after the 3-dose infant series (7 months of age)

• GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose

  1 month after the toddler dose (16 months of age)

• Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).

  Within 4 days after Dose 1 of the infant series (2 Months of Age)

Study Arms (2)

1

EXPERIMENTAL

13vPnC

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

2

ACTIVE COMPARATOR

7vPnC

Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)

Interventions

13-valent pneumococcal conjugate vaccine (13vPnC) BIOLOGICAL

13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

1

7-valent pneumococcal conjugate vaccine (7vPnC) BIOLOGICAL

7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

2

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Memorial Hospital - Linko

Taoyuan Hsien, 333, Taiwan

Location

Related Publications (1)

• Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine. 2012 Mar 9;30(12):2054-9. doi: 10.1016/j.vaccine.2011.12.054. Epub 2011 Dec 22.

  PMID: 22198517 DERIVED

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Limitations and Caveats

Geometric Mean Concentration Outcome Measures were identified as secondary analysis in the study protocol, but are included to maintain consistency with other postings for this program.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: June 5, 2008
• Primary Completion: January 13, 2010
• Study Completion: January 13, 2010
• Last Updated: October 7, 2022
• Results First Posted: May 12, 2011

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

TW (2)