Infections, StreptococcalPhase 3NCT02447432

A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants

A Phase 3 study testing Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation), Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation) and DTPw-HBV/Hib in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 42 to 76 daysHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal
What is being tested?: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation), Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation) and DTPw-HBV/Hib
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 1 siteBangladesh
Study dates: 11 Jun 2015to 22 May 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 42 to 76 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits).
A male or female between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. For all subjects, the consent form should be countersigned by a witness.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born full-term (i.e., after a gestation period from 37 to 42 weeks).

Who cannot join

Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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. Inhaled and topical steroids are allowed.
Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
Administration or planned administration of a vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of study vaccines and ending 30 days after with the following exceptions:
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

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Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b and/or S. pneumoniae.
History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H. influenzae type b disease.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
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.
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 for oral, axillary or tympanic route, or ≥ 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary.
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 (Hepatitis B immunoglobulins at birth are allowed).
Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

GSK Investigational Site
Dhaka, 1000

Other trials in Bangladesh

About this study

Official title: Study to Compare Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants

The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first secondary objective), after administration of a 3-dose primary vaccination course at 6, 10 and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at 6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).

In addition, the study will also assess the safety, reactogenicity, immunogenicity and antibody persistence (approximately 7 months following primary vaccination) of the 4-dose presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18 weeks of age followed by a booster dose at 38 weeks.

This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9 months of age.

Conditions: Infections, Streptococcal
Being tested: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation), Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation), DTPw-HBV/Hib
Keywords: Invasive disease by Streptococcus pneumoniae (S. pneumoniae) (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media), Infants, Multidose, Haemophilus influenzae, Streptococcus pneumoniae, Preservative, Safety, Pneumonia, Immunogenicity, Pneumococcal conjugate vaccine, Acute otitis media caused by non-typeable Haemophilus influenzae (NTHi)., Respiratory tract infections
Medical subject headings: Streptococcal Infections, Meningitis, Pneumonia, Toxemia, Otitis Media, Haemophilus Infections, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation)Biological
Also called 10Pn, 10PN-PD-DiT, GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT)
4 doses by intramuscular injection in the right left anterolateral thigh
Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation)Biological
Also called Synflorix™, GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT) vaccine
4 doses by intramuscular injection in the right anterolateral thigh
DTPw-HBV/HibBiological
Also called GSK Biologicals' diphtheria-tetanus-whole cell pertussis-hepatitis B and Haemophilus influenzae type b vaccine
3 doses by intramuscular injection in the left anterolateral thigh

Study groups in NCT02447432
Study group	Role	What they receive
10Pn_4d Group	Experimental	Subjects received 10Pn-PD-DIT, in its investigational 4-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2). Receives: Biological: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation); Biological: DTPw-HBV/Hib
10Pn Group	Active comparator	Subjects received 10Pn-PD-DIT, in its licensed 1-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2). Receives: Biological: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation); Biological: DTPw-HBV/Hib

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine

Secondary outcomes (13)

Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002)
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.
Measured: At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001)
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.
Measured: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002)
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.
Measured: At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.
Measured: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.
Measured: At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001)
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.
Dose 4 = 10Pn-PD-DIT at 18 weeks of age.
Measured: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002)
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).
Measured: Within the 4-day (Days 0-3) period after booster vaccination
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001)
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.
Dose 4 = 10Pn-PD-DIT at 18 weeks of age.
Measured: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002)
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (>) 39.5°C.
Measured: Within the 4-day (Days 0-3) period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)
An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Measured: Within the 31-day (Days 0-30) period post primary vaccination, across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)
An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Measured: Within the 31-day (Days 0-30) period post booster vaccination
Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)
An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.
Measured: From Month 0 to Month 4
Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study
An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.
Measured: From Day 0 to Month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 201522 May 2016

First posted18 May 2015 (estimated)
Study start11 Jun 2015
Primary completion23 Jan 2016
Study completion22 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, StreptococcalStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02447432
Sponsor's protocol ID: 200799
Status last verified: Jun 2018
First submitted: 7 May 2015
Last updated: 2 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Zaman K, Zaman SF, Zaman F, Aziz A, Faisal SB, Traskine M, Habib MA, Ruiz-Guinazu J, Borys D. Immunologic non-inferiority and safety of the investigational pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) 4-dose vial presentation compared to the licensed PHiD-CV 1-dose vial presentation in infants: A phase III randomized study. Vaccine. 2018 Jan 29;36(5):698-706. doi: 10.1016/j.vaccine.2017.12.034. Epub 2017 Dec 23.
PubMed 29277353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Compare Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
ClinicalTrials.gov ID: NCT02447432
Acronym / sponsor ID: 200799
Conditions: Infections, Streptococcal
Keywords: Invasive disease by Streptococcus pneumoniae (S. pneumoniae) (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media), Infants, Multidose, Haemophilus influenzae, Streptococcus pneumoniae, Preservative, Safety, Pneumonia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 11 Jun 2015
Primary completion: 23 Jan 2016 (actual)
Study completion: 22 May 2016 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 16 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9 months of age.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
10Pn_4d Group	Experimental	Biological: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation), Biological: DTPw-HBV/HibSubjects received 10Pn-PD-DIT, in its investigational 4-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).
10Pn Group	Active comparator	Biological: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation), Biological: DTPw-HBV/HibSubjects received 10Pn-PD-DIT, in its licensed 1-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).

Who may qualify

Ages: 42 to 76 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits).
A male or female between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. For all subjects, the consent form should be countersigned by a witness.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born full-term (i.e., after a gestation period from 37 to 42 weeks).

Key exclusion criteria (18 listed)

Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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. Inhaled and topical steroids are allowed.
Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
Administration or planned administration of a vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of study vaccines and ending 30 days after with the following exceptions:

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
Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation)Also: 10Pn, 10PN-PD-DiT, GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT)4 doses by intramuscular injection in the right left anterolateral thigh	Biological	10Pn_4d Group
Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation)Also: Synflorix™, GSK Biologicals' 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate GSK1024850A (10Pn-PD-DiT) vaccine4 doses by intramuscular injection in the right anterolateral thigh	Biological	10Pn Group
DTPw-HBV/HibAlso: GSK Biologicals' diphtheria-tetanus-whole cell pertussis-hepatitis B and Haemophilus influenzae type b vaccine3 doses by intramuscular injection in the left anterolateral thigh	Biological	10Pn Group, 10Pn_4d Group

Primary outcome

Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)
Time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

13 secondary outcomes

Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002)
Time frame: At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001)
Time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002)
Time frame: At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)
Time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)
Time frame: At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001)
Time frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine
Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002)
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001)
Time frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002)
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)
Time frame: Within the 31-day (Days 0-30) period post primary vaccination, across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)
Time frame: Within the 31-day (Days 0-30) period post booster vaccination
Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)
Time frame: From Month 0 to Month 4
Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study
Time frame: From Day 0 to Month 9

Results and safety

Results posted to the registry on 16 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10Pn_4d Group	160	155
Synflorix Group	160	147

Primary outcome: Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)

Time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine. Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	10Pn_4d Group n = 154	Synflorix Group n = 146
ANTI-1	2.78 (2.43 to 3.18)	3.03 (2.60 to 3.54)
ANTI-4	4.23 (3.69 to 4.84)	3.87 (3.33 to 4.51)
ANTI-5	5.12 (4.46 to 5.88)	5.30 (4.59 to 6.12)
ANTI-6B	1.23 (0.95 to 1.57)	1.37 (1.05 to 1.79)
ANTI-7F	5.52 (4.90 to 6.22)	5.79 (5.06 to 6.62)
ANTI-9V	4.60 (3.98 to 5.32)	4.07 (3.34 to 4.95)
ANTI-14	4.97 (4.05 to 6.10)	4.84 (3.91 to 5.99)
ANTI-18C	19.58 (16.65 to 23.03)	21.18 (17.90 to 25.06)

10Pn_4d Group vs Synflorix Group: GMCs ratio: 1.09 (95% CI 0.89 to 1.33)
10Pn_4d Group vs Synflorix Group: GMCs ratio: 0.92 (95% CI 0.75 to 1.12)
10Pn_4d Group vs Synflorix Group: GMCs ratio: 1.03 (95% CI 0.85 to 1.26)

Population analysed: The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms and Unsolicited AEs: during 31 days post vaccination period. SAEs: during the whole study period (from Day 0 to Month 9).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10Pn_4d Group	4 of 160 (2.5%)	120 of 160 (75%)	1 of 160
Synflorix Group	9 of 160 (5.6%)	126 of 160 (78.8%)	1 of 160

Limitations and caveats (from the sponsor): None reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29277353Zaman K, Zaman SF, Zaman F, Aziz A, Faisal SB, Traskine M, Habib MA, Ruiz-Guinazu J, Borys D. Immunologic non-inferiority and safety of the investigational pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) 4-dose vial presentation compared to the licensed PHiD-CV 1-dose vial presentation in infants: A phase III randomized study. Vaccine. 2018 Jan 29;36(5):698-706. doi: 10.1016/j.vaccine.2017.12.034. Epub 2017 Dec 23.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request 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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) (time frame: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02447432, which also lists 1 linked publication.

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 2 Aug 2018.