Consistency & immunogenicity study of 3 lots of GSK's Hib conjugate vaccine versus ActHIB & Pentacel in healthy infantsN/A
Trial overview
Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL) and ≥ 1.0 µg/mL
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with anti-Protein-D (anti-D) and anti-Protein-T (anti-T) antibody concentrations ≥ 0.1 International Units per milliliter (IU/mL)
Timeframe: At 1 month after last dose of primary vaccination
Anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations
Timeframe: At 1 month after last dose of primary vaccination
Anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous hemagglutinin (anti-FHA) antibody concentrations
Timeframe: At 1 month after last dose of primary vaccination
Anti-Streptococcus pneumoniae (S.pneumoniae) antibody concentrations
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with seroresponse (95%) to anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous hemagglutinin (anti-FHA)
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with anti-Polio 1,2,3 antibody titres greater than or equal to cut-off value
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations ≥ 1.0 µg/mL
Timeframe: At 1 month after booster vaccination
Anti-protein-D (anti-D) and anti-protein-T (anti-T) antibody concentrations
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with any solicited local symptoms
Timeframe: During a 4-day follow-up period (Days 0-3) following any vaccination
Number of subjects with any solicited general symptoms
Timeframe: During a 4-day follow-up period (Days 0-3) following any vaccination
Number of subjects with any unsolicited adverse events (AEs).
Timeframe: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: From Day 0 until 6 months following the last primary dose
Number of subjects with AEs of specific interest (AESIs)
Timeframe: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first
Number of subjects with seroresponse (90%) to anti-PT, anti-PRN and anti-FHA
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with anti-PT, anti-PRN and anti-FHA antibody concentrations ≥ 5 EL.U/mL
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-Hepatitis B (Anti-HBs) antibody concentrations
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with S.pneumoniae antibody concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL
Timeframe: At 1 month after the last dose of primary vaccination
Antibody titers for Poliovirus types 1, 2 and 3
Timeframe: At 1 month after last dose of primary vaccination
Number of subjects with anti-HBs antibody concentrations greater than or equal to cut-off values
Timeframe: At 1 month after last dose of primary vaccination
Anti-polyribosylribitol phosphate (PRP) antibody concentrations
Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-Hepatitis B (Anti-HBs) antibody concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL
Timeframe: Prior to the booster vaccination
Number of subjects with anti-HB antibody concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL
Timeframe: Prior to booster vaccination
Number of subjects with Anti-PT, anti-FHA and anti-PRN concentrations ≥ 5 EL.U/mL
Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination
Anti-poliovirus types 1, 2, and 3 antibody titres and titres ≥ 8
Timeframe: Prior to the booster vaccination
Number of subjects with anti-Polio-1,2,3 antibody titers ≥ 8
Timeframe: Prior to booster vaccination
Number of subjects with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, respectively.
Timeframe: Prior to the booster vaccination and 1 month after the booster vaccination
Number of subjects with any solicited local symptoms
Timeframe: Within 4 days (Days 0-3) following the booster dose
Number of subjects with any solicited general symptoms
Timeframe: Within 4 days (Days 0-3) following the booster dose
Number of subjects with AEs of specific interest (AESIs)
Timeframe: From booster dose until 6 months following receipt of the booster dose
Number of subjects with any unsolicited adverse events (AEs).
Timeframe: Within 31 days (Day 0 to Day 30) following the booster dose
Number of subjects with serious adverse events (SAEs)
Timeframe: From the booster dose until 6 months following receipt of the booster dose
Anti-FHA, Anti-PRN and Anti-PT antibody concentrations
Timeframe: pre-booster and one month after booster vaccination
- Subjects for whom the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits).
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the subject's parent/LAR.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of minimum 36 weeks.
- Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
Subjects for whom the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose.
- Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment. All vaccines can be administered to persons with a minor illness.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Concurrent participation in another clinical study, up to 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Child in care.
- History of intussusception.
- History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
- History of Severe Combined Immunodeficiency Disease.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.