Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Vaccines, Pneumococcal Clinical Trial

Official title:

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366678
• Other study ID #: 6096A1-008
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2006
• Last updated: July 6, 2012
• Start date: October 2006
• Est. completion date: November 2008

Study information

• Verified date: July 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthUnited States: Food and Drug Administration
• 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 (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

Inclusion Criteria:

• Healthy 2-month-old infants.

• Available for the entire study period.

Exclusion criteria:

· Known contraindication to vaccines.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
• 7-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.

Drug:
• Pentavac
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria, Tetanus, Hemophilus Influenza Type b (Hib), Poliomyelitis (Type 1, 2, 3), Pertussis Toxin (PT) and Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group	Percentage of participants achieving predefined antibody threshold levels =0.1 IU/mL for diphtheria, =0.1 IU/mL for tetanus, = 0.15 µg/mL for Hib polyribosylribitol phosphate (PRP), antibody titer =1:8 for polio and =5 EU/mL for pertussis (PT and FHA) with the corresponding 95% CI for each concomitant antigen are presented.	One Month After the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)	No
Primary	Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Diphtheria Toxoid and Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)	No
Primary	Geometric Mean Concentration (GMC) for Haemophilus Influenzae Type b (Hib) in 13vPnC Group Relative to 7vPnC Group		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)	No
Primary	Geometric Mean Concentration (GMC) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) for Poliomyelitis (Type 1, Type 2 and Type 3) in 13vPnC Group Relative to 7vPnC Group		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)	No
Primary	Geometric Mean Concentration (GMC) as Measured by ELISA for Pertussis Toxin (PT) and Pertussis Filamentous Hemagglutinin (FHA) in 13vPnC Group Relative to 7vPnC Group		One month after the 3-Dose Infant Series (at 5 months of age) and the Toddler Dose (at 13 months of age)	No
Primary	Percentage of Participants Achieving a Pneumococcal Antibody Level =0.35µg/mL (ELISA) After the 3-Dose Infant Series of 13vPnC	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold =0.35µg/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.	One month after the 3-Dose Infant Series (at 5 months of age)	No
Primary	Percentage of Participants Reporting Pre-Specified Local Reactions	Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.	During the 4-day period after each dose	Yes
Primary	Percentage of Participants Reporting Pre-Specified Systemic Events	Systemic events (fever [fv] = 37.5 degrees Celsius [C], fever = 38 C but = 39 C, fever >39 C but = 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.	During the 4-day period after each dose	Yes
Primary	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the 3-Dose Infant Series of 13vPnC	Antibody GMC 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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated.	One month after the 3-Dose Infant Series (at 5 months of age)	No
Secondary	Percentage of Participants Achieving a Pneumococcal Antibody Level =0.35µg/mL (ELISA) After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups	Percentages of participants achieving World health Organization (WHO) predefined antibody threshold =0.35µg/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.	One month after the toddler dose (at 13 months of age)	No
Secondary	Pneumococcal Geometric Mean Concentration (GMC) Before and After the Toddler Dose in the 13vPnC/13vPnC, 7vPnC/7vPnC and 7vPnC/13vPnC Groups	Antibody GMC as measured by ELISA for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	One month after the Toddler Dose (at 13 months of age)	No
Secondary	Percentage of Participants Achieving Antibody Titer =1:8 After the Toddler Dose in 13vPnC/13vPnC and 7vPnC/13vPnC Groups	Percentage of participants achieving functional antibody titer =1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	One month after the toddler dose (at 13 months of age)	No
Secondary	Geometric Mean Titer (GMT) in 13vPnC/13vPnC and 7vPnC/13vPnC Groups After the Toddler Dose	GMT as measured by opsonophagocytic activity assay (OPA) for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	One month after the toddler dose (at 13 months of age)	No