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

A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN

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.

Study Overview

• Status: Completed
• Conditions: Vaccines; Pneumococcal Conjugate Vaccine
• Intervention / Treatment: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taoyuan Hsien, Taiwan, 333
    • Chang Gung Memorial Hospital - Linko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; 13vPnC	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
ACTIVE_COMPARATOR: 2; 7vPnC	Biological: 7-valent pneumococcal conjugate vaccine (7vPnC); 7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 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.	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 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	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.	1 month after toddler dose (16 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 Infant Series	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.	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	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.	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).	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 Dose 1 of the infant series (2 Months of Age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 Dose 2 of the infant series (4 months of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 Dose 3 of the infant series (6 months of age)
Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 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 (15 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 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 Dose 1 of the infant series (2 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)	Systemic events (any fever >=38 degrees 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 Dose 2 of the infant series (4 months of age)
Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)	Systemic events (any fever >=38 degrees 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 dose 3 of the infant series (6 months of age)
Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).	Systemic events (any fever >=38 degrees 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 (15 months of age)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2008
• Primary Completion (ACTUAL): January 13, 2010
• Study Completion (ACTUAL): January 13, 2010

Study Registration Dates

• First Submitted: May 29, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (ESTIMATE): June 3, 2008

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Prevention against pneumococcal disease
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6096A1-3004; B1851005 (OTHER: Alias Study Number); 2008-004766-40 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.