Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers

NCT01577732 | Completed Phase 3 Results

• 2 other identifiers: 1153892013-002538-18
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.

Conditions

Acellular Pertussis; Haemophilus Influenzae Type b; Tetanus; Poliomyelitis; Diphtheria; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines

Keywords

booster; Infanrix-IPV+HibTM; DTPa-IPV/Hib; Vietnamese toddlers

Outcome Measures

Primary Outcomes (4)

• Number of Subjects Reporting Solicited Local Symptoms

  Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

  Within the 4-day (Days 0-3) follow up period after vaccination.

• Number of Subjects Reporting Solicited General Symptoms

  Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.

  Within the 4-day (Days 0-3) follow up period after vaccination.

• Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

  An unsolicited AE was 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. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

  Within the 31-day (Days 0-30) follow up period after vaccination.

• Number of Subjects Reporting Any Serious Adverse Events (SAEs).

  SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

  During the entire study period (Days 0-30).

Study Arms (1)

Infanrix-IPV+Hib Group

EXPERIMENTAL

Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.

Biological: Infanrix-IPV+Hib™

Interventions

Infanrix-IPV+Hib™ BIOLOGICAL

Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.

Infanrix-IPV+Hib Group

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
• A male or female between, and including, 12 and 24 months of age at the time of vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who were primed with three doses of a DTP and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• 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 booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or Hib disease or vaccination.
• History of any neurological disorders or seizures.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• Acute disease and/or fever at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Haiphong, Vietnam

Location

Related Publications (1)

• Anh DD, Van Der Meeren O, Karkada N, Assudani D, Yu TW, Han HH. Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study. Hum Vaccin Immunother. 2016 Mar 3;12(3):655-7. doi: 10.1080/21645515.2015.1084451.

  PMID: 26337197 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Haemophilus Infections; Tetanus; Poliomyelitis; Diphtheria

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Gram-Positive Bacterial Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Corynebacterium Infections; Actinomycetales 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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 16, 2012
• Study Start: December 8, 2012
• Primary Completion: April 9, 2013
• Study Completion: April 9, 2013
• Last Updated: January 21, 2020
• Results First Posted: May 5, 2014

Record last verified: 2020-01

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

VN (1)