Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b
Brief summary
DTaP-HB-PRP\ T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. Primary Objectives: * To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\ T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth. * To describe the effect of a booster dose of DTaP-HB-PRP\ T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP\ T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth. Secondary Objective: * To describe the safety profile of the booster dose of the DTaP-HB-PRP\ T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).
Detailed description
This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP\ T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP\ T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881).
Interventions
BIOLOGICALDTaP-HB PRP~T Combined Vaccine
0.5 mL, Intramuscular (IM)
BIOLOGICALDTaP-HB-PRP~T vaccine
0.5 mL, IM
BIOLOGICALOral Polio Vaccine
Oral co-administered with study vaccine.
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive) * Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP\ T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth * Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) * Able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances * Chronic illness at a stage that could interfere with trial conduct or completion * Blood or blood-derived products received in the last 3 months * Any vaccination in the 4 weeks preceding the trial vaccination * Vaccination planned in the 4 weeks following the trial vaccination * Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion * History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically) * Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the primary series * Thrombocytopenia or a bleeding disorder contraindicating IM vaccination * Serious adverse event related to any vaccination in the AL201 study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Day 0 (pre-vaccination) and Day 28 post-booster vaccination | Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Day 0 (pre-vaccination) and Day 28 post-vaccination | Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination. |
| Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Day 0 up to Day 7 after vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable. |
Countries
Philippines
Participant flow
Recruitment details
Participants were randomized and enrolled from 06 August 2007 to 29 July 2008 in 2 clinic centers in the Philippines.
Pre-assignment details
A total of 1843 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV Participants received a booster dose of the DTaP-Hep B-PRP\
T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP\
T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201. | 1,230 |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV Participants received a booster dose of the DTaP-Hep B-PRP\
T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201. | 613 |
| Total | 1,843 |
Baseline characteristics
| Characteristic | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 613 Participants | 1230 Participants | 1843 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.1 Months STANDARD_DEVIATION 1.95 | 15.1 Months STANDARD_DEVIATION 1.96 | 15.1 Months STANDARD_DEVIATION 1.96 |
| Region of Enrollment Philippines | 613 Participants | 1230 Participants | 1843 Participants |
| Sex: Female, Male Female | 302 Participants | 629 Participants | 931 Participants |
| Sex: Female, Male Male | 311 Participants | 601 Participants | 912 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 411 / 1,230 | 216 / 613 |
| serious Total, serious adverse events | 3 / 1,230 | 0 / 613 |
Outcome results
Primary
Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.
Time frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination
Population: Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep B Pre-booster (N = 93, 103) | 81 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep B Post-booster (N = 93, 105) | 91 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Pre-booster (N = 93, 105) | 78 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Post-booster (N = 93, 105) | 93 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Pre-booster (N = 93, 105) | 72 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Post-booster (N = 93, 105) | 93 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus Pre-booster (N = 93, 105) | 93 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus Post-booster (N = 93, 105) | 93 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertussis 4-Fold increase (N = 89, 101) | 85 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertussis booster response (N = 89, 101) | 87 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA 4-Fold increase (N = 91, 103) | 80 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA booster response (N = 91, 103) | 89 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA 4-Fold increase (N = 91, 103) | 102 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep B Pre-booster (N = 93, 103) | 80 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus Pre-booster (N = 93, 105) | 105 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep B Post-booster (N = 93, 105) | 103 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertussis booster response (N = 89, 101) | 101 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Pre-booster (N = 93, 105) | 105 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus Post-booster (N = 93, 105) | 105 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Post-booster (N = 93, 105) | 105 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA booster response (N = 91, 103) | 102 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Pre-booster (N = 93, 105) | 68 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertussis 4-Fold increase (N = 89, 101) | 100 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Post-booster (N = 93, 105) | 103 Participants |
Secondary
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: GMTs were assessed in a sub-set of the participants available for the endpoint, the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep Bs Post-booster (N = 93, 105) | 4224 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus pre-booster (N = 93, 105) | 0.364 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Post-booster (N = 93, 105) | 58.1 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus post-booster (N = 93, 105) | 11.6 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep B Pre-booster (N = 93, 103) | 71.6 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertusiss pre-booster (N = 89, 101) | 7.34 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertusiss post-booster (N = 93, 105) | 128 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Pre-booster (N = 93, 105) | 0.016 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA Pre-booster (N = 91,103) | 14.0 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Pre-booster (N = 93, 105) | 0.889 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA Post-booster (N = 91,103) | 204 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Post-booster (N = 93, 105) | 1.36 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA Post-booster (N = 91,103) | 158 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep B Pre-booster (N = 93, 103) | 42.2 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Hep Bs Post-booster (N = 93, 105) | 3673 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Pre-booster (N = 93, 105) | 5.32 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-PRP Post-booster (N = 93, 105) | 242 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Pre-booster (N = 93, 105) | 0.014 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Diphtheria Post-booster (N = 93, 105) | 1.43 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus pre-booster (N = 93, 105) | 0.504 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Tetanus post-booster (N = 93, 105) | 24.7 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertusiss post-booster (N = 93, 105) | 185 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-FHA Pre-booster (N = 91,103) | 2.21 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anti-Pertusiss pre-booster (N = 89, 101) | 6.82 Titers |
Secondary
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.
Time frame: Day 0 up to Day 7 after vaccination
Population: Safety was assessed on the safety analysis (intent-to-treat) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Injection site Swelling post-vaccination | 7 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Vomiting post-vaccination | 3 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Injection site Erythema post-vaccination | 7 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Crying post-vaccination | 98 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Extensive swelling of vaccinated limb | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Crying post-vaccination | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Injection site Erythema post-vaccination | 272 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Somnolence post-vaccination | 114 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Pyrexia post-vaccination | 137 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Somnolence post-vaccination | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Injection site Swelling post-vaccination | 211 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anorexia post-vaccination | 97 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Pyrexia post-vaccination | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Anorexia post-vaccination | 2 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Injection site Pain post-vaccination | 10 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Irritability post-vaccination | 224 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Vomiting post-vaccination | 53 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Irritability post-vaccination | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Injection site Pain post-vaccination | 411 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Irritability post-vaccination | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Injection site Pain post-vaccination | 216 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Injection site Pain post-vaccination | 1 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Injection site Erythema post-vaccination | 136 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Injection site Erythema post-vaccination | 3 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Injection site Swelling post-vaccination | 120 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Injection site Swelling post-vaccination | 4 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Extensive swelling of vaccinated limb | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Pyrexia post-vaccination | 70 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Pyrexia post-vaccination | 3 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Vomiting post-vaccination | 33 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Vomiting post-vaccination | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Crying post-vaccination | 58 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Crying post-vaccination | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Somnolence post-vaccination | 73 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Somnolence post-vaccination | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Anorexia post-vaccination | 53 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Grade 3 Anorexia post-vaccination | 3 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV) | Irritability post-vaccination | 114 Participants |