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

Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688870
• Other study ID #: 6096A1-3004
• Secondary ID: B18510052008-004
• Status: Completed
• Phase: Phase 3
• Start date: June 5, 2008
• Est. completion date: January 13, 2010

Study information

• Verified date: September 2022
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 13, 2010
• Est. primary completion date: January 13, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Days to 98 Days

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Conjugate Vaccine
• Vaccines

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine (13vPnC)
13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
• 7-valent pneumococcal conjugate vaccine (7vPnC)
7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital - Linko	Taoyuan Hsien

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)