Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines
2 other identifiers
interventional
850
1 country
23
Brief Summary
The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age. In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2010
Typical duration for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2010
CompletedFirst Posted
Study publicly available on registry
November 8, 2010
CompletedStudy Start
First participant enrolled
November 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2012
CompletedResults Posted
Study results publicly available
January 31, 2019
CompletedMay 10, 2019
April 1, 2019
1.4 years
November 4, 2010
September 29, 2017
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).
One month after primary immunization (At Month 3)
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.
One month after primary immunization (At Month 3)
Antibody Concentrations Against Protein D (Anti-PD)
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.
One month after primary immunization (At Month 3)
Secondary Outcomes (22)
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A
One month after primary immunization (At Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Within the 4-day (Days 0-3) period following booster vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Within the 4-day (Days 0-3) period following booster vaccination
- +17 more secondary outcomes
Study Arms (18)
Group IIBU
EXPERIMENTALImmediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose
Group DIBU
ACTIVE COMPARATORDelayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose
Group NIBU
ACTIVE COMPARATORNo ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose
Group IPARA
EXPERIMENTALImmediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose
Group DPARA
EXPERIMENTALDelayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose
Group NPARA
ACTIVE COMPARATORNo paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose
Group IIBU-IIBU
EXPERIMENTAL1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination
Group IIBU-DIBU
EXPERIMENTAL1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination
Group IIBU-NIBU
EXPERIMENTAL1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Group DIBU-IIBU
EXPERIMENTAL1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination
Group DIBU-DIBU
EXPERIMENTAL1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination
Group DIBU-NIBU
EXPERIMENTAL1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Group NIBU-IIBU
EXPERIMENTAL1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination
Group NIBU-DIBU
EXPERIMENTAL1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination
Group NIBU-NIBU
ACTIVE COMPARATOR1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Group IPARA-NPARA
EXPERIMENTALsubjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination
Group DPARA-IPARA
EXPERIMENTALsubjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination
Group NPARA-IPARA
EXPERIMENTALsubjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination
Interventions
Intramuscular injection, 4 doses
Intramuscular injection, 3 doses
Intramuscular injection, 1 dose
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
You may not qualify if:
- Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use 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 product (.
- Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period.
- Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
- History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
- History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
- History of any seizures or progressive neurological disease.
- Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during entire study period.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (23)
GSK Investigational Site
Bacau, 600316, Romania
GSK Investigational Site
Brasov, 500063, Romania
GSK Investigational Site
Brasov, 500260, Romania
GSK Investigational Site
Brasov, 500366, Romania
GSK Investigational Site
Brăila, 810289, Romania
GSK Investigational Site
Brăila, 810346, Romania
GSK Investigational Site
Bucharest, 030442, Romania
GSK Investigational Site
Bucharest, 050734, Romania
GSK Investigational Site
Bucharest, 051821, Romania
GSK Investigational Site
Bucharest, 077190, Romania
GSK Investigational Site
Călăraşi, 910160, Romania
GSK Investigational Site
Cluj-Napoca, 400217, Romania
GSK Investigational Site
Constanța, 900709, Romania
GSK Investigational Site
Constanța, 900721, Romania
GSK Investigational Site
Galati, 800099, Romania
GSK Investigational Site
Galati, 800179, Romania
GSK Investigational Site
Galati, 800235, Romania
GSK Investigational Site
Galati, 800322, Romania
GSK Investigational Site
Galati, 800394, Romania
GSK Investigational Site
Iași, 700115, Romania
GSK Investigational Site
Pantelimon, 77145, Romania
GSK Investigational Site
Sibiu, 550166, Romania
GSK Investigational Site
Timișoara, 300593, Romania
Related Publications (1)
Falup-Pecurariu O, Man SC, Neamtu ML, Chicin G, Baciu G, Pitic C, Cara AC, Neculau AE, Burlea M, Brinza IL, Schnell CN, Sas V, Lupu VV, Francois N, Swinnen K, Borys D. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017 Mar 4;13(3):649-660. doi: 10.1080/21645515.2016.1223001. Epub 2016 Aug 19.
PMID: 27541270BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2010
First Posted
November 8, 2010
Study Start
November 12, 2010
Primary Completion
March 28, 2012
Study Completion
December 8, 2012
Last Updated
May 10, 2019
Results First Posted
January 31, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.