Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b
Brief summary
The present trial is a follow-up of AL203 study (NCT00343889). Primary Objectives: To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP\ T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine \[OPV\]). Secondary Objective: To describe the safety profile of a booster dose of DTaP-HB-PRP\ T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.
Detailed description
Study participants will receive a booster vaccination of DTaP-HB-PRP\ T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).
Interventions
BIOLOGICALDTaP-HB-PRP~T vaccine
0.5 mL, Intramuscular
BIOLOGICALTritanrix-HepB/Hib™
0.5 mL, Intramuscular
BIOLOGICALOral Polio Vaccine
0.5 mL, Oral
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive) * Participated in the AL203 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 * 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 intramuscular (IM) vaccination * Serious adverse event related to any vaccination in the AL203 study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 28 Days post-vaccination | Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization 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 at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio. |
| Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Day 28 post-vaccination | Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Day 0 up to Day 7 post-vaccination | Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - 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 21 September 2007 to 03 December 2007 in 2 clinical centers in the Philippines.
Pre-assignment details
A total of 362 participants who met the inclusion but not 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 DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. | 182 |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. | 180 |
| Total | 362 |
Baseline characteristics
| Characteristic | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 180 Participants | 182 Participants | 362 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 | 15.9 Months STANDARD_DEVIATION 0.942 | 15.9 Months STANDARD_DEVIATION 0.946 | 15.9 Months STANDARD_DEVIATION 0.945 |
| Region of Enrollment Philippines | 180 Participants | 182 Participants | 362 Participants |
| Sex: Female, Male Female | 88 Participants | 97 Participants | 185 Participants |
| Sex: Female, Male Male | 92 Participants | 85 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 101 / 182 | 142 / 180 |
| serious Total, serious adverse events | 14 / 182 | 7 / 180 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination
Time frame: Day 28 post-vaccination
Population: Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in 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 Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP Pre-booster (N = 98, 98) | 0.908 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hepatitis B Pre-booster (N = 98, 98) | 6.75 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hepatitis B Post-booster (N = 98, 98) | 119 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP Post-booster (N = 98, 98) | 64.4 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria Pre-booster (N = 98, 98) | 0.016 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria Post-booster (N = 98, 98) | 2.81 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus Pre-booster (N = 98, 98) | 0.382 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus Post-booster (N = 98, 98) | 15.8 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis Pre-booster (N = 96, 92) | 9.11 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis Post-booster (N = 98, 98) | 199 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA Pre-booster (N = 95, 93) | 15.0 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA Post-booster (N = 97, 98) | 233 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA Pre-booster (N = 95, 93) | 2.10 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus Pre-booster (N = 98, 98) | 0.500 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hepatitis B Pre-booster (N = 98, 98) | 17.5 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis Post-booster (N = 98, 98) | 105 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hepatitis B Post-booster (N = 98, 98) | 1352 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP Pre-booster (N = 98, 98) | 3.76 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus Post-booster (N = 98, 98) | 14.7 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP Post-booster (N = 98, 98) | 103 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA Post-booster (N = 97, 98) | 117 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria Pre-booster (N = 98, 98) | 0.013 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis Pre-booster (N = 96, 92) | 6.94 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria Post-booster (N = 98, 98) | 1.15 Titers |
Primary
Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization 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 at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio.
Time frame: 28 Days post-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 | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hep B, Pre-booster (N = 98, 98) | 36 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hep B, Post-booster (N = 98, 98) | 81 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP, Pre-booster (N = 98, 98) | 82 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP, Post-booster (N = 98, 98) | 97 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria, Pre-booster (N = 98, 98) | 67 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria, Post-booster (N = 98, 98) | 97 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus, Pre-booster (N = 98, 97) | 98 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus, Post-booster (N = 98, 98) | 98 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis, 4-Fold Increase (N = 96, 92) | 94 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis, Booster response (N = 96, 92) | 95 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA, 4-Fold Increase (N = 94, 93) | 89 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA, Booster response (N = 94, 93) | 93 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA, 4-Fold Increase (N = 94, 93) | 92 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hep B, Pre-booster (N = 98, 98) | 58 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus, Pre-booster (N = 98, 97) | 97 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hep B, Post-booster (N = 98, 98) | 94 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis, Booster response (N = 96, 92) | 85 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP, Pre-booster (N = 98, 98) | 97 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus, Post-booster (N = 98, 98) | 98 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP, Post-booster (N = 98, 98) | 98 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-FHA, Booster response (N = 94, 93) | 93 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria, Pre-booster (N = 98, 98) | 59 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis, 4-Fold Increase (N = 96, 92) | 83 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria, Post-booster (N = 98, 98) | 97 Participants |
Secondary
Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - 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 post-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 At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Swelling | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Vomiting | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Erythema | 2 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying | 23 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Extensive swelling of vaccinated limb | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Crying post-vaccination | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema | 71 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination | 22 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia | 39 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Somnolence | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling | 21 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia | 24 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Pyrexia | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Anorexia | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Pain | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability | 38 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting | 16 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Irritability | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain | 65 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Irritability | 1 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain | 124 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Pain | 9 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema | 90 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Erythema | 1 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling | 47 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Swelling | 2 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Extensive swelling of vaccinated limb | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia | 46 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Pyrexia | 2 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting | 15 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Vomiting | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying | 42 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Crying post-vaccination | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination | 41 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Somnolence | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia | 39 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Anorexia | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability | 71 Participants |