DiphtheriaPhase 3NCT03128489
Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants
A Phase 3 study testing Infanrix-IPV/Hib in people with Diphtheria and Acellular Pertussis, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of care. Read more about this study
- Who is it for?
- Ages 6 to 9 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Acellular Pertussis, Haemophilus Influenzae Type b
- What is being tested?
- Infanrix-IPV/Hib
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Aug 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects' parent(s)/Legally Acceptable Representatives [LARs] 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 9 weeks of age (42-69 days) at the time of the first vaccination.
- Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born full-term [i.e., after a gestation period of 37 to less than 42 completed weeks (259 to 293 days)].
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before first dose of study vaccine (Day-29 to Day 0), or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth to within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the last dose of vaccine with the exception of human rotavirus vaccine, hepatitis B vaccine, pneumococcal conjugate vaccine and other vaccines given as a part of the national immunisation schedule, that are allowed at any time during the study period.
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- 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 vaccine/product.
- History of diphtheria, tetanus, pertussis, poliomyelitis and Hib disease.
- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease prior to study enrolment, with the exception of a birth dose of hepatitis B and/or Baccillus Calmette-Guerin (BCG) vaccines and/or oral poliovirus (OPV) vaccine as per local standard of care. The BCG vaccination should occur at least 30 days prior to first dose of vaccination in the study.
- 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.
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
About this study
Official title: Immunogenicity and Safety of GSK Biologicals' DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) (SB213503) in Healthy Indian Infants
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of care.
Read the detailed description
- Experimental design: Phase III, open-label, non-randomised, multi-centric, single-country study with a single group.
- Duration of the study: The intended duration of the study will be approximately 3 months per subject.
- Treatment group and vaccination schedule: All subjects will receive three doses of the vaccine at 6, 10 and 14 weeks of age.
- DTPa-IPV/Hib Group: Subjects who will receive DTPa-IPV/Hib vaccine (Infanrix-IPV/Hib).
Other routine registered childhood vaccinations as part of National Immunisation Programme are permitted. Information regarding vaccine administered since birth until study completion will be collected and documented.
- Being tested
- Infanrix-IPV/Hib
- Keywords
- Safety, Infanrix™-IPV/Hib, Immunogenicity, Indian infants, Combined vaccine
- Medical subject headings
- Diphtheria, Haemophilus Infections, Tetanus, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix-IPV/HibBiological
Subjects will receive (Infanrix-IPV/Hib) as three-dose primary vaccination course at 6, 10 and 14 weeks of age. The vaccine will be administered intramuscularly, at a 90-degree angle into the anterolateral side of the thigh on the right side. The vaccine should not be administered in the buttock.
| Study group | Role | What they receive |
|---|---|---|
| DTPa-IPV/Hib Group | Experimental | All subjects will receive three doses of primary vaccination at 6, 10 and 14 weeks of age. Receives: Biological: Infanrix-IPV/Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seroprotected subjects in terms of anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
A seroprotected subject is a subject whose anti-D/anti-T antibody concentration is greater than or equal to (≥) 0.1 International Units per millilitre (IU/ml).
Measured: One month after the third dose of primary vaccination (Month 3)
Number of seroprotected subjects in terms of anti-poliomyelitis (anti-Polio) types 1, 2 and 3 antibodies.
A seroprotected subject is a subject whose anti-Polio 1, 2 and 3 antibody titers are greater than or equal to (≥) 8 median effective dose (ED50).
Measured: One month after the third dose of primary vaccination (Month 3)
Number of seroprotected subjects in terms of anti-polysaccharide Polyribosyl-Ribitol Phosphate (anti-PRP) antibodies.
A seroprotected subject is a subject whose anti-PRP antibody concentration is greater than or equal to (≥) 0.15 micrograms per millilitre (µg/ml).
Measured: One month after the third dose of primary vaccination (Month 3)
Number of subjects with vaccine response to pertussis toxoid (PT), Filamentous Haemagglutinin (FHA) and pertactin (PRN) antigens.
Vaccine response to pertussis antigens is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lesser than the assay cut-off value), or maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ assay cut-off value).
Measured: One month after the third dose of primary vaccination (Month 3)
Secondary outcomes (15)
Anti-D and anti-T antibody concentrations.
Antibody concentrations are expressed as geometric mean concentrations (GMCs).
Measured: One month after the third dose of primary vaccination (Month 3).
Anti-Polio type 1, 2 and 3 antibody titres.
Antibody titres are expressed as geometric mean titres (GMTs).
Measured: One month after the third dose of primary vaccination (Month 3)
Anti-PRP antibody concentrations.
Antibody concentrations are expressed as geometric mean concentrations (GMCs).
Measured: One month after the third dose of primary vaccination (Month 3).
Anti-PT, anti-FHA and anti-PRN antibody concentrations.
Antibody concentrations are expressed as geometric mean concentrations (GMCs).
Measured: One month after the third dose of primary vaccination (Month 3)
Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies.
A seropositive subject is a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations above the cut-off value of 5 Enzyme-linked immunosorbent assay (ELISA) Units per millilitre (EL.U/mL).
Measured: One month after the third dose of primary vaccination (Month 3).
Anti-PT, anti-FHA and anti-PRN antibody concentrations.
Antibody concentrations are expressed as geometric mean concentrations (GMCs).
Measured: Before the first dose of primary vaccination (Day 0)
Anti-Polio type 1, 2 and 3 antibody titres.
Antibody titres are expressed as geometric mean titres (GMTs).
Measured: Before the first dose of primary vaccination (Day 0)
Anti-PRP antibody concentrations.
Antibody concentrations are expressed as geometric mean concentrations (GMCs).
Measured: Before the first dose of primary vaccination (Day 0)
Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies.
A seropositive subject is a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations above the cut-off value of 5 EL.U/mL.
Measured: Before the first dose of primary vaccination (Day 0)
Number of seroprotected subjects in terms of anti-Polio type 1, 2 and 3 antibodies.
A seroprotected subject is a subject whose anti-Polio 1, 2 and 3 antibody titers are greater than or equal to (≥) 8 ED50.
Measured: Before the first dose of primary vaccination (Day 0)
Number of seroprotected subjects in terms of anti-PRP antibodies.
A seroprotected subject is a subject whose anti-PRP antibody concentration is greater than or equal to (≥) 0.15 µg/ml.
Measured: Before the first dose of primary vaccination (Day 0)
Number of subjects with solicited local symptoms.
Solicited local symptoms assessed are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimetres (mm) of injection site.
Measured: During the 4-day period (Days 0-3) following each vaccination.
Number of subjects with solicited general symptoms.
Solicited general symptoms assessed are drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevents normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day period (Days 0-3) following each vaccination.
Number of subjects with unsolicited adverse events (AEs).
An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: During the 31-day period (Days 0-30) following each vaccination.
Number of subjects with serious adverse events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From dose 1 (Day 0) until study end (Month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Why it stopped: The study is cancelled due to reassessment of the medical need for the vaccine in India. Cancellation is not related to vaccine's safety and/or efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128489
- Sponsor's protocol ID
- 201124
- Other IDs
- 2013-004361-14
- Status last verified
- Dec 2017
- First submitted
- 20 Apr 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of GSK Biologicals' DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) (SB213503) in Healthy Indian Infants
- ClinicalTrials.gov ID
- NCT03128489
- Acronym / sponsor ID
- 201124
- Keywords
- Safety, Infanrix™-IPV/Hib, Immunogenicity, Indian infants, Combined vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is cancelled due to reassessment of the medical need for the vaccine in India. Cancellation is not related to vaccine's safety and/or efficacy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority. The 6, 10 and 14 week schedule reflects the current Indian standard of care.
Detailed description
- Experimental design: Phase III, open-label, non-randomised, multi-centric, single-country study with a single group.
- Duration of the study: The intended duration of the study will be approximately 3 months per subject.
- Treatment group and vaccination schedule: All subjects will receive three doses of the vaccine at 6, 10 and 14 weeks of age.
- DTPa-IPV/Hib Group: Subjects who will receive DTPa-IPV/Hib vaccine (Infanrix-IPV/Hib).
Other routine registered childhood vaccinations as part of National Immunisation Programme are permitted. Information regarding vaccine administered since birth until study completion will be collected and documented.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTPa-IPV/Hib Group | Experimental | Biological: Infanrix-IPV/HibAll subjects will receive three doses of primary vaccination at 6, 10 and 14 weeks of age. |
Who may qualify
- Ages
- 6 to 9 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects' parent(s)/Legally Acceptable Representatives [LARs] 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 9 weeks of age (42-69 days) at the time of the first vaccination.
- Written informed consent obtained from the parents/LARs of the subject prior to performing any study specific procedure.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born full-term [i.e., after a gestation period of 37 to less than 42 completed weeks (259 to 293 days)].
Key exclusion criteria (18 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before first dose of study vaccine (Day-29 to Day 0), or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Chronic administration of immunosuppressants or other immune-modifying drugs from birth to within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs at any time during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infanrix-IPV/HibSubjects will receive (Infanrix-IPV/Hib) as three-dose primary vaccination course at 6, 10 and 14 weeks of age. The vaccine will be administered intramuscularly, at a 90-degree angle into the anterolateral side of the thigh on the right side. The vaccine should not be administered in the buttock. | Biological | DTPa-IPV/Hib Group |
Primary outcome
Number of seroprotected subjects in terms of anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
Time frame: One month after the third dose of primary vaccination (Month 3)
A seroprotected subject is a subject whose anti-D/anti-T antibody concentration is greater than or equal to (≥) 0.1 International Units per millilitre (IU/ml).
Number of seroprotected subjects in terms of anti-poliomyelitis (anti-Polio) types 1, 2 and 3 antibodies.
Time frame: One month after the third dose of primary vaccination (Month 3)
A seroprotected subject is a subject whose anti-Polio 1, 2 and 3 antibody titers are greater than or equal to (≥) 8 median effective dose (ED50).
Number of seroprotected subjects in terms of anti-polysaccharide Polyribosyl-Ribitol Phosphate (anti-PRP) antibodies.
Time frame: One month after the third dose of primary vaccination (Month 3)
A seroprotected subject is a subject whose anti-PRP antibody concentration is greater than or equal to (≥) 0.15 micrograms per millilitre (µg/ml).
Number of subjects with vaccine response to pertussis toxoid (PT), Filamentous Haemagglutinin (FHA) and pertactin (PRN) antigens.
Time frame: One month after the third dose of primary vaccination (Month 3)
Vaccine response to pertussis antigens is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lesser than the assay cut-off value), or maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ assay cut-off value).
15 secondary outcomes
Anti-D and anti-T antibody concentrations.
Time frame: One month after the third dose of primary vaccination (Month 3).
Anti-Polio type 1, 2 and 3 antibody titres.
Time frame: One month after the third dose of primary vaccination (Month 3)
Anti-PRP antibody concentrations.
Time frame: One month after the third dose of primary vaccination (Month 3).
Anti-PT, anti-FHA and anti-PRN antibody concentrations.
Time frame: One month after the third dose of primary vaccination (Month 3)
Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies.
Time frame: One month after the third dose of primary vaccination (Month 3).
Anti-PT, anti-FHA and anti-PRN antibody concentrations.
Time frame: Before the first dose of primary vaccination (Day 0)
Anti-Polio type 1, 2 and 3 antibody titres.
Time frame: Before the first dose of primary vaccination (Day 0)
Anti-PRP antibody concentrations.
Time frame: Before the first dose of primary vaccination (Day 0)
Number of seropositive subjects in terms of anti-PT, anti-FHA and anti-PRN antibodies.
Time frame: Before the first dose of primary vaccination (Day 0)
Number of seroprotected subjects in terms of anti-Polio type 1, 2 and 3 antibodies.
Time frame: Before the first dose of primary vaccination (Day 0)
Number of seroprotected subjects in terms of anti-PRP antibodies.
Time frame: Before the first dose of primary vaccination (Day 0)
Number of subjects with solicited local symptoms.
Time frame: During the 4-day period (Days 0-3) following each vaccination.
Number of subjects with solicited general symptoms.
Time frame: During the 4-day period (Days 0-3) following each vaccination.
Number of subjects with unsolicited adverse events (AEs).
Time frame: During the 31-day period (Days 0-30) following each vaccination.
Number of subjects with serious adverse events (SAEs).
Time frame: From dose 1 (Day 0) until study end (Month 3)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infanrix-IPV/Hib in people with Diphtheria and Acellular Pertussis, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of seroprotected subjects in terms of anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies. (time frame: One month after the third dose of primary vaccination (Month 3)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.