Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

Phase 3

Completed

• Conditions: Vaccines, Pneumococcal
• Interventions: Biological: 13 valent pneumococcal conjugate vaccine; Biological: 7vPnc pneumococcal conjugate vaccine

• Registration Number: NCT00373958
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2009-02-26
• Disposition First Submitted QC: 2009-07-31
• Disposition First Posted: 2009-10-02
• Results First Submitted: 2010-03-26
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-17
• Last Update Submitted: 2013-01-17
• Results First Posted: 2013-02-21
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 666

Inclusion Criteria

• Healthy 2-month-old infants.
• Available for the entire study period.

Exclusion criteria:

• Previous vaccination with any vaccine before the start of the study.
• Known contraindication to vaccination.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
13vPnC vaccine	13 valent pneumococcal conjugate vaccine	-
7vPnC vaccine	7vPnc pneumococcal conjugate vaccine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Pre-specified Systemic Events	Within 7 days after each dose	Systemic events (any fever \[Fv\] ≥ 38 degrees Celsius \[C\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \[urticaria\], use of antipyretic medication \[med\] to treat or prevent symptoms \[sx\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series	One month after the 3-dose infant series (7 months of age)	Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 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.
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series	One Month After the Infant Series (7 months of age)	Predefined Antibody Levels for Haemophilus Influenzae Type b (\[Hib\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \[IU\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \[FHA\] 40.5 Elisa Units \[EU\]/mL, Pertussis toxoid \[PT\] 16.5 EU/mL, Pertussis pertactin \[PRN\] 26 EU/mL).
Percentage of Participants Reporting Pre-specified Local Reactions	Within 7 days after each dose	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\[Sig.\], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (\[Mod.\], 2.5 to 7.0 cm); Severe (\[Sev.\], \> 7.0 cm). Participants may have been represented in more than 1 category.
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose	1 Month After the Toddler Dose	Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose	One month after infant series and one month after toddler dose	Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 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.
Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	one month after the toddler dose
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)	One month after toddler dose (13 to 16 months of age)
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	one month after the toddler dose	Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.
Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose	one month after the toddler dose
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose	one month after the infant series and the toddler dose	Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.