Trial record 6 of 11 for:    Open Studies | "Haemophilus influenzae type b"

Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02096263
First received: March 21, 2014
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.


Condition Intervention Phase
Poliomyelitis
Diphtheria
Haemophilus Influenzae Type b
Tetanus
Acellular Pertussis
Hepatitis B
Biological: Infanrix hexa
Biological: Pediarix
Biological: ActHIB
Biological: Pentacel
Biological: Engerix-B
Biological: Infanrix
Biological: Hiberix
Biological: Prevnar13
Biological: Rotarix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of immunogenicity with respect to pertussis components of the study vaccines Infanrix hexa and Pediarix [ Time Frame: 1 month after the third dose of the primary vaccination (Month 7) ] [ Designated as safety issue: No ]
    Anti-PT, anti-FHA, anti-PRN antibody concentrations.


Secondary Outcome Measures:
  • Evaluation of immunogenicity (other parameters) with respect to the pertussis component of the study vaccines Infanrix hexa, Pentacel and Pediarix [ Time Frame: 1 month after the third dose of the primary vaccination (Month 7) ] [ Designated as safety issue: No ]
    Anti-PT, anti-FHA, anti-PRN seropositivity status

  • Evaluation of immunogenicity (other parameters) with respect to the pertussis component of the study vaccine Pentacel [ Time Frame: 1 month after the third dose of the primary vaccination (Month 7) ] [ Designated as safety issue: No ]
    Anti-PT, anti-FHA, anti-PRN antibody concentrations

  • Evaluation of immunogenicity with respect to the other components of the study vaccines Infanrix hexa, Pediarix, ActHIB, Pentacel and Engerix-B [ Time Frame: 1 month after the third dose of the primary vaccination (Month 7) ] [ Designated as safety issue: No ]
    Anti-D, anti-T, anti-HBs, anti-poliovirus types 1, 2 and 3 and anti-PRP seroprotection status, anti-PRP antibody concentrations ≥1.0 µg/mL and antibody concentrations/titers

  • Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 - Day 3) after each vaccination ] [ Designated as safety issue: No ]
    ‒ Occurrence of each solicited local symptom (any, ≥Grade 2, Grade 3 and symptoms requiring medical attention) (Infanrix hexa, Pediarix, ActHIB, Pentacel and Engerix-B) ‒ Occurrence of each solicited general symptom (any, ≥Grade 2, Grade 3, symptoms requiring medical attention, related and Grade 3 related)

  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of specific adverse events [ Time Frame: From Day 0 up to 6 months post primary vaccination ] [ Designated as safety issue: No ]
    Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)

  • Occurrence of Serious adverse events (SAEs) [ Time Frame: From Day 0 up to 6 months post primary vaccination ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to all study vaccines in terms of antibody concentration and titres [ Time Frame: Before the booster dose (Dose 4) (Study month 13-16) ] [ Designated as safety issue: No ]
    Anti-D, anti-T, anti- PT, anti-FHA and anti-PRN, anti-HBs, anti-PRP and anti-poliovirus 1, 2, 3 seroprotection/ seropositivity status, anti-PRP antibody concentrations ≥1 µg/mL and antibody concentrations/ titers

  • Immunogenicity with respect to the study vaccine Pentacel [ Time Frame: 1 month after the booster dose (Dose 4) (Study month 14-17) ] [ Designated as safety issue: No ]
    ‒ Anti-D, anti-T, anti- PT, anti-FHA and anti-PRN, anti-PRP seroprotection/ seropositivity status and antibody concentrations. - Anti-PT, anti-FHA and anti-PRN booster response. - Anti-PRP antibody concentrations ≥1 µg/mL. - Anti-D and anti-T antibody concentrations ≥1 IU/mL

  • Immunogenicity with respect to the study vaccine Infanrix [ Time Frame: 1 month after the booster dose (Dose 4) (Study month 14-17) ] [ Designated as safety issue: No ]
    ‒ Anti-D, anti-T, anti- PT, anti-FHA and anti-PRN seroprotection/ seropositivity status and antibody concentrations. - Anti-PT, anti-FHA and anti-PRN booster response. - Anti-D and anti-T antibody concentrations ≥1 IU/mL

  • Immunogenicity with respect to the study vaccines ActHIB and Hiberix [ Time Frame: 1 month after the booster dose (Dose 4) (Study month 14-17) ] [ Designated as safety issue: No ]
    ‒ Anti-PRP seroprotection status and antibody concentrations.‒ Anti-PRP antibody concentrations ≥1 µg/mL

  • Occurence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 - Day 3) after booster vaccination (Infanrix, Hiberix, ActHIB and Pentacel) ] [ Designated as safety issue: No ]
    ‒ Occurrence of each solicited local symptom (any, ≥Grade 2, Grade 3 and symptoms requiring medical attention). - Occurrence of each solicited general symptom (any, ≥Grade 2, Grade 3, symptoms requiring medical attention, related and Grade 3 related).

  • Occurence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after booster vaccination ] [ Designated as safety issue: No ]
  • Occurence of specific adverse events [ Time Frame: From the booster dose (Study month 13-16) up to 1 month after the booster vaccination (Study month 14-17) ] [ Designated as safety issue: No ]
    Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)

  • Occurrence of SAEs [ Time Frame: From the booster dose (Study month 13-16) up to 1 month after the booster vaccination (Study month 14-17) ] [ Designated as safety issue: No ]

Estimated Enrollment: 585
Study Start Date: April 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hexa Lot A Group
Subjects in this group will receive 3 doses of Infanrix hexa (lot A) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and Hiberix vaccines at 15-18 months of age
Biological: Infanrix hexa
3 doses administered intramuscularly in the right thigh.
Biological: Infanrix
1 dose administered intramuscularly in the right thigh
Biological: Hiberix
1 dose administered intramuscularly in the left thigh
Biological: Prevnar13
3 doses administered intramuscularly in the lower left thigh
Biological: Rotarix
2 doses administered orally
Experimental: Hexa Lot B Group
Subjects in this group will receive 3 doses of Infanrix hexa (lot B) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and Hiberix vaccines at 15-18 months of age
Biological: Infanrix hexa
3 doses administered intramuscularly in the right thigh.
Biological: Infanrix
1 dose administered intramuscularly in the right thigh
Biological: Hiberix
1 dose administered intramuscularly in the left thigh
Biological: Prevnar13
3 doses administered intramuscularly in the lower left thigh
Biological: Rotarix
2 doses administered orally
Experimental: Hexa Lot C Group
Subjects in this group will receive 3 doses of Infanrix hexa (lot C) co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and Hiberix vaccines at 15-18 months of age
Biological: Infanrix hexa
3 doses administered intramuscularly in the right thigh.
Biological: Infanrix
1 dose administered intramuscularly in the right thigh
Biological: Hiberix
1 dose administered intramuscularly in the left thigh
Biological: Prevnar13
3 doses administered intramuscularly in the lower left thigh
Biological: Rotarix
2 doses administered orally
Experimental: Pedia Group
Subjects in this group will receive 3 doses of Pediarix and ActHIB co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. Subjects will receive a booster dose of Infanrix and ActHIB vaccines at 15-18 months of age
Biological: Pediarix
3 doses administered intramuscularly in the right thigh
Biological: ActHIB
4 doses administered intramuscularly in the upper left thigh
Biological: Infanrix
1 dose administered intramuscularly in the right thigh
Biological: Prevnar13
3 doses administered intramuscularly in the lower left thigh
Biological: Rotarix
2 doses administered orally
Active Comparator: Penta Group
Subjects in this group will receive 3 doses of Pentacel and Engerix-B* co-administered with Prevnar13 at 2, 4 and 6 months of age and Rotarix at 2 and 4 months of age. *Subjects in the Penta Group who have received a dose of hepatitis B vaccine from birth up to 30 days prior to study vaccination should not receive Engerix-B at 4 months of age (Visit 2). Subjects will receive a booster dose of Pentacel vaccine at 15-18 months of age.
Biological: Pentacel
4 doses administered intramuscularly in the right thigh
Biological: Engerix-B
2 or 3 doses administered intramuscularly in the upper left thigh
Biological: Prevnar13
3 doses administered intramuscularly in the lower left thigh
Biological: Rotarix
2 doses administered orally

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects' parent(s)/ LAR(s) 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 12 weeks of age at the time of the first vaccination.
  • Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks [259 to 293 days]).
  • Written informed consent obtained from parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • 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 enrolment.

Exclusion Criteria:

  • Child in care
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose 4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of the study:

    • Inactivated influenza and hepatitis A vaccines are allowed throughout the study.
    • Routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. Routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in US.
  • 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 product (pharmaceutical product or device).
  • History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis B diseases.
  • Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including yeast).
  • Hypersensitivity to latex.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders including seizures.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • History of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
  • History of Severe Combined Immunodeficiency Disease (SCID).
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred route for recording temperature in this study will be rectal for Epoch 001 and axillary for Epoch 002.
    • Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096263

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 45 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02096263     History of Changes
Other Study ID Numbers: 117119
Study First Received: March 21, 2014
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Infants
Safety
Healthy
Infanrix Hexa
Immunogenicity

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 18, 2014