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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02096263
First Posted: March 26, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Parallel Assignment
Masking: None (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) ]
    Immunogenicity results were not available at the time this summary was written. Missing data will be added when results become available.


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) ]
    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) ]
    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) ]
    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

  • Number of subjects with solicited local symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1 ]
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling = > 5 millimeters (mm); Grade 3 Redness/Swelling = > 20 mm; Grade 2 Pain = Moderate: Painful when limb is moved and interferes with every day activities; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.

  • Number of subjects with solicited local symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2 ]
    The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling = > 5 millimeters (mm); Grade 3 Redness/Swelling = > 20 mm; Grade 2 Pain = Moderate: Painful when limb is moved and interferes with every day activities; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.

  • Number of subjects with solicited local symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3 ]
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling = > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe) = > 20 mm; Grade 2 Pain = Moderate: Painful when limb is moved and interferes with every day activities; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA

  • Number of subjects with solicited local symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following any dose. ]
    The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe) = > 5 millimeters (mm); Grade 3 Redness/Swelling = > 20 mm; Grade 2 Pain = Moderate: Painful when limb is moved and interferes with every day activities; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.

  • Number of subjects with solicited general symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever = > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever = > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.

  • Number of subjects with solicited general symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever = > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever = > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.

  • Number of subjects with solicited general symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever = > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever = > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.

  • Number of subjects with solicited general symptoms. [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following any dose. ]
    The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever = > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever = > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.

  • Number of subjects with specific adverse events [ Time Frame: Until the Database Freeze date (19Jun 2015) for Primary Epoch analysis ]
    Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)

  • Number of subjects with unsolicited adverse events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period. ]
    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  • Number of subjects with serious adverse events (SAEs) [ Time Frame: Until the Database Freeze date (19Jun 2015) for Primary Epoch analysis ]
    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

  • 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) ]
    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) ]
    ‒ 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) ]
    ‒ 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) ]
    ‒ 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) ]
    ‒ 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).

  • 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) ]

Enrollment: 591
Actual Study Start Date: April 16, 2014
Study Completion Date: November 13, 2015
Primary Completion Date: February 6, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infanrix hexa Group
Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Infanrix hexa™ (lot A, lot B or lot C as per the group allocation) co-administered with Prevnar13® at 2, 4 and 6 months of age and Rotarix® at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix® was administered orally. Subjects received a booster dose of Infanrix® and Hiberix™ at 15-18 months of age by intramuscular injection in the anterolateral thigh.
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
Active Comparator: Pediarix Group
Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 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. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix® was administered orally. Subjects received a booster dose of Infanrix® and ActHIB® at 15-18 months of age by intramuscular injection in the anterolateral thigh.
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: Pentacel Group
Subjects between, and including, 6 and 12 weeks of age at the time of the vaccination received, in the Primary Phase of the study, 3 doses of Pentacel® and Engerix® co-administered with Prevnar13® at 2, 4 and 6 months of age and Rotarix® at 2 and 4 months of age. The injectable vaccines were administered by intramuscular injection in the anterolateral thigh, while Rotarix® was administered orally. Subjects received a booster dose of Pentacel® at 15-18 months of age by intramuscular injection in the anterolateral thigh.
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096263


  Show 44 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02096263     History of Changes
Other Study ID Numbers: 117119
First Submitted: March 21, 2014
First Posted: March 26, 2014
Last Update Posted: October 12, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Infants
Safety
Healthy
Infanrix Hexa
Immunogenicity

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Poliomyelitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs