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 paediatric vaccinations in Italy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
605
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
Unnamed facility
Taranto, Apulia, Italy
Unnamed facility
Naples, Campania, Italy
Unnamed facility
Naples, Campania, Italy
Unnamed facility
Bologna, Emilia-Romagna, Italy
Percentage of Participants Reporting Pre-Specified Local Reactions
Local reactions were collected 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 or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time frame: During the 4-day period after each dose
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.
Time frame: One month after the infant series (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)
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Unnamed facility
Rome, Lazio, Italy
Unnamed facility
Rome, Lazio, Italy
Unnamed facility
Genoa, Liguria, Italy
Unnamed facility
Milan, Lombardy, Italy
Unnamed facility
Novara, Piedmont, Italy
Unnamed facility
Sassari, Sardinia, Italy
...and 3 more locations
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.
Time frame: One month after the infant series (6 months of age) and the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
GMC of Polio as measured using a polio in vitro plaque neutralization.
Time frame: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
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.
Time frame: one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
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.
Time frame: One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Percentages of Participants achieving 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.
Time frame: One month after the toddler dose (12 months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
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.
Time frame: One month after toddler dose (12 months of age)