Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03128489
Other study ID # 201124
Secondary ID 2013-004361-14
Status Withdrawn
Phase Phase 3
First received April 20, 2017
Last updated December 22, 2017
Start date December 1, 2017
Est. completion date August 1, 2018

Study information

Verified date December 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of care.


Description:

- Experimental design: Phase III, open-label, non-randomised, multi-centric, single-country study with a single group.

- Duration of the study: The intended duration of the study will be approximately 3 months per subject.

- Treatment group and vaccination schedule: All subjects will receive three doses of the vaccine at 6, 10 and 14 weeks of age.

- DTPa-IPV/Hib Group: Subjects who will receive DTPa-IPV/Hib vaccine (Infanrix-IPV/Hib).

Other routine registered childhood vaccinations as part of National Immunisation Programme are permitted. Information regarding vaccine administered since birth until study completion will be collected and documented.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Weeks to 9 Weeks
Eligibility Inclusion Criteria:

- Subjects' parent(s)/Legally Acceptable Representatives [LARs] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

- A male or female between, and including, 6 and 9 weeks of age (42-69 days) at the time of the first vaccination.

- Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure.

- Healthy subjects as established by medical history and clinical examination before entering into the study.

- Born full-term [i.e., after a gestation period of 37 to less than 42 completed weeks (259 to 293 days)].

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before first dose of study vaccine (Day-29 to Day 0), or planned use during the study period.

- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

- Chronic administration of immunosuppressants or other immune-modifying drugs from birth to within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.

- Administration of long-acting immune-modifying drugs at any time during the study period.

- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the last dose of vaccine with the exception of human rotavirus vaccine, hepatitis B vaccine, pneumococcal conjugate vaccine and other vaccines given as a part of the national immunisation schedule, that are allowed at any time during the study period.

- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

- History of diphtheria, tetanus, pertussis, poliomyelitis and Hib disease.

- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease prior to study enrolment, with the exception of a birth dose of hepatitis B and/or Baccillus Calmette-Guerin (BCG) vaccines and/or oral poliovirus (OPV) vaccine as per local standard of care. The BCG vaccination should occur at least 30 days prior to first dose of vaccination in the study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

- Family history of congenital or hereditary immunodeficiency.

- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

- Major congenital defects or serious chronic illness.

- History of any neurological disorders or seizures.

- Acute disease and/or fever at the time of enrolment.

- Fever is defined as temperature =37.5°C/99.5°F for oral, axillary or tympanic route, or = 38.0°C/100.4°F for rectal route.

- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Study Design


Intervention

Biological:
Infanrix-IPV/Hib
Subjects will receive (Infanrix-IPV/Hib) as three-dose primary vaccination course at 6, 10 and 14 weeks of age. The vaccine will be administered intramuscularly, at a 90-degree angle into the anterolateral side of the thigh on the right side. The vaccine should not be administered in the buttock.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary Number of seroprotected subjects in terms of anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies. A seroprotected subject is a subject whose anti-D/anti-T antibody concentration is greater than or equal to (=) 0.1 International Units per millilitre (IU/ml). One month after the third dose of primary vaccination (Month 3)
Primary Number of seroprotected subjects in terms of anti-poliomyelitis (anti-Polio) types 1, 2 and 3 antibodies. A seroprotected subject is a subject whose anti-Polio 1, 2 and 3 antibody titers are greater than or equal to (=) 8 median effective dose (ED50). One month after the third dose of primary vaccination (Month 3)
Primary Number of seroprotected subjects in terms of anti-polysaccharide Polyribosyl-Ribitol Phosphate (anti-PRP) antibodies. A seroprotected subject is a subject whose anti-PRP antibody concentration is greater than or equal to (=) 0.15 micrograms per millilitre (µg/ml). One month after the third dose of primary vaccination (Month 3)
Primary Number of subjects with vaccine response to pertussis toxoid (PT), Filamentous Haemagglutinin (FHA) and pertactin (PRN) antigens. Vaccine response to pertussis antigens is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lesser than the assay cut-off value), or maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations = assay cut-off value). One month after the third dose of primary vaccination (Month 3)
Secondary Anti-D and anti-T antibody concentrations. Antibody concentrations are expressed as geometric mean concentrations (GMCs). One month after the third dose of primary vaccination (Month 3).
Secondary Anti-Polio type 1, 2 and 3 antibody titres. Antibody titres are expressed as geometric mean titres (GMTs). One month after the third dose of primary vaccination (Month 3)
Secondary Anti-PRP antibody concentrations. Antibody concentrations are expressed as geometric mean concentrations (GMCs). One month after the third dose of primary vaccination (Month 3).
Secondary Anti-PT, anti-FHA and anti-PRN antibody concentrations. Antibody concentrations are expressed as geometric mean concentrations (GMCs). One month after the third dose of primary vaccination (Month 3)
Secondary Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies. A seropositive subject is a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations above the cut-off value of 5 Enzyme-linked immunosorbent assay (ELISA) Units per millilitre (EL.U/mL). One month after the third dose of primary vaccination (Month 3).
Secondary Anti-PT, anti-FHA and anti-PRN antibody concentrations. Antibody concentrations are expressed as geometric mean concentrations (GMCs). Before the first dose of primary vaccination (Day 0)
Secondary Anti-Polio type 1, 2 and 3 antibody titres. Antibody titres are expressed as geometric mean titres (GMTs). Before the first dose of primary vaccination (Day 0)
Secondary Anti-PRP antibody concentrations. Antibody concentrations are expressed as geometric mean concentrations (GMCs). Before the first dose of primary vaccination (Day 0)
Secondary Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies. A seropositive subject is a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations above the cut-off value of 5 EL.U/mL. Before the first dose of primary vaccination (Day 0)
Secondary Number of seroprotected subjects in terms of anti-Polio type 1, 2 and 3 antibodies. A seroprotected subject is a subject whose anti-Polio 1, 2 and 3 antibody titers are greater than or equal to (=) 8 ED50. Before the first dose of primary vaccination (Day 0)
Secondary Number of seroprotected subjects in terms of anti-PRP antibodies. A seroprotected subject is a subject whose anti-PRP antibody concentration is greater than or equal to (=) 0.15 µg/ml. Before the first dose of primary vaccination (Day 0)
Secondary Number of subjects with solicited local symptoms. Solicited local symptoms assessed are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimetres (mm) of injection site. During the 4-day period (Days 0-3) following each vaccination.
Secondary Number of subjects with solicited general symptoms. Solicited general symptoms assessed are drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevents normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. During the 4-day period (Days 0-3) following each vaccination.
Secondary Number of subjects with unsolicited adverse events (AEs). An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. During the 31-day period (Days 0-30) following each vaccination.
Secondary Number of subjects with serious adverse events (SAEs). Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. From dose 1 (Day 0) until study end (Month 3)
See also
  Status Clinical Trial Phase
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Completed NCT02538211 - The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01689324 - Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Phase 1/Phase 2
Completed NCT01444781 - Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Phase 3
Completed NCT01214889 - Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Phase 3
Completed NCT00804284 - Database Surveillance Safety Study of PENTACEL® Vaccine N/A
Completed NCT00514709 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Phase 3
Completed NCT00534833 - Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ Phase 3
Completed NCT00379977 - Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age Phase 3
Completed NCT00772369 - Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Phase 4
Completed NCT00879827 - Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants Phase 3
Completed NCT01457495 - Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly Phase 2
Completed NCT01267058 - Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Phase 3
Completed NCT02853929 - Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery Phase 4
Completed NCT02858440 - A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Phase 3
Recruiting NCT06049940 - Safety and Immunogenicity of Tetanus Vaccine, Adsorbed in 18~44 Years Old Population Phase 3
Completed NCT00385255 - Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults Phase 3