Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

NCT01309646 | Completed Phase 3 Results

• 2 other identifiers: 1142602012-004137-16
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 11

Brief Summary

This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.

Conditions

Poliomyelitis; Tetanus; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b

Keywords

Primary vaccination; combination vaccine; South Korea

Outcome Measures

Primary Outcomes (4)

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

  A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).

  At Month 5

• Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.

  A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.

  At Month 5

• Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

  A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).

  At Month 5

• Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.

  Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).

  At Month 5

Secondary Outcomes (13)

• Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).

  At Month 0 and Month 5

• Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations

  At Month 0

• Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

  At Month 0

• Concentrations for Anti-D and Anti-T Antibodies.

  At Month 0 and Month 5

• Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.

  At Month 0

Study Arms (2)

Infanrix-IPV+Hib Group

EXPERIMENTAL

Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.

Biological: Infanrix™-IPV+Hib; Biological: Synflorix™; Biological: Rotarix™

Infanrix IPV Group

ACTIVE COMPARATOR

Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.

Biological: Infanrix™ IPV; Biological: Hiberix™; Biological: Synflorix™; Biological: Rotarix™

Interventions

Infanrix™-IPV+Hib BIOLOGICAL

Intramuscular, 3 doses

Infanrix-IPV+Hib Group

Infanrix™ IPV BIOLOGICAL

Intramuscular, 3 doses

Infanrix IPV Group

Hiberix™ BIOLOGICAL

Intramuscular, 3 doses

Infanrix IPV Group

Synflorix™ BIOLOGICAL

Intramuscular, 3 doses

Infanrix IPV Group; Infanrix-IPV+Hib Group

Rotarix™ BIOLOGICAL

Oral, 2 doses

Infanrix IPV Group; Infanrix-IPV+Hib Group

Eligibility Criteria

• Age: 42 Days - 69 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A male or female between, and including, 42 and 69 days of age at the time of the first vaccination.
• Born after a gestation period of 37 to 42 weeks inclusive.
• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
• 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.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease.
• 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(s).
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Daegu, 700-712, South Korea

Location

GSK Investigational Site

Goyang, South Korea

Location

GSK Investigational Site

GyeongSangNam-do, 641-560, South Korea

Location

GSK Investigational Site

Iksan, 570-711, South Korea

Location

GSK Investigational Site

Jeonju Jeonbuk, 561-712, South Korea

Location

GSK Investigational Site

Seongnam-si, 463-712, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 139-706, South Korea

Location

GSK Investigational Site

Suwon City, Gyeonggi-do, 442-723, South Korea

Location

GSK Investigational Site

Uijeongbu, Gyeonggi-do, 480-717, South Korea

Location

GSK Investigational Site

Wonju-si Kangwon-do, 220-701, South Korea

Location

Related Publications (1)

• Kim KH, Kim CS, Kim HM, Kim JD, Ma SH, Kim DH, Hwang PH, Han JW, Lee TJ, Kim JH, Karkada N, Mesaros N, Sohn WY, Kim JH. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. Hum Vaccin Immunother. 2019;15(2):317-326. doi: 10.1080/21645515.2018.1536588. Epub 2018 Nov 15.

  PMID: 30431387 BACKGROUND

MeSH Terms

Conditions

Poliomyelitis; Tetanus; Diphtheria; Haemophilus Infections

Interventions

Hiberix; PHiD-CV vaccine; RIX4414 vaccine

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Corynebacterium Infections; Actinomycetales Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 7, 2011
• Study Start: March 4, 2011
• Primary Completion: February 24, 2012
• Study Completion: February 24, 2012
• Last Updated: November 27, 2019
• Results First Posted: April 2, 2013

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

KR (11)