The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
604
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentage 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.
Time frame: One month after 3-dose infant series (5 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody concentration/geometric mean concentration (GMC) 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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Time frame: One month after 3-dose infant series (5 months of age)
Percentage of Participants Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.
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.
Time frame: One month after 3-dose infant series (5 months of age)
Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody functionality/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.
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Unnamed facility
Bad Kreuznach, Germany
Unnamed facility
Bad Saulgau, Germany
Unnamed facility
Bad Sobernheim, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Birkenfeld, Germany
...and 41 more locations
Time frame: One month after 3-dose infant series (5 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Predefined Antibody Levels for Haemophilus Influenzae Type b (0.15 µg/mL or 1.0 µg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units \[IU\]/mL) and for Hepatitis B (≥ 10.0 mIU/mL).
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by 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.
Time frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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.
Time frame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.
Time frame: Day 1 through 4 after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 through 4 after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)
Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, decreased sleep, and hives \[urticaria\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: Day 1 through 4 after each dose