Submitted by: Pearly Cheng 2018-09-13 00:00:00 Last Updated by: Jeverly Ann S. Principe 2018-09-25 14:36:31 Export to PDF

A prospective, Phase I, randomized, controlled, open label study to assess the reactogenicity, safety and immunogenicity of a combined liquid DTwP-rHepB-Hib-IPV vaccine when administered to healthy children 16-24 months of age as a single dose.

PHRR180925-001885

BECT/HEXA/IP-050

2018-CT0452

Reactogenicity, safety and immunogenicity study of a combined liquid DTwP-rHepB-Hib-IPV vaccine when administered in healthy children 16-24 months of age.

This study is a prospective, Phase I, randomized, controlled, open label study to assess the reactogenicity, safety and immunogenicity of a combined liquid DTwP-rHepB-Hib-IPV vaccine when administered to healthy children 16-24 months of age as a single dose.
 
This study will enroll 48 subjects for the study.
 
The study design is 3 steps staggered enrollment. This is to ensure maximum safety of participating children.
 
For the first 16 subject enrolled, subject will be followed up for seven days post vaccination (Day 0- Day6). Day 7 all safety data collected will be reviewed by Joint Safety Team. During this time, investigator will not proceed with enrolment until site receive a written communication documenting the safety evaluation and the recommendation on the study to continuation by JST Chair/co-Chair.  This design will continue to the 2nd 16 subjects enrolled up to 3rd 16 subjects enrolled.
 
At the end of the study, safety data from all vaccinated subjects, collected up to the day 28 post-vaccination will be reviewed by joint safety team.

Start Date Duration in Months Target Completion Date Actual Completion Date
2018-12-03 6 2019-06-03 0000-00-00

Ongoing

Institution Classification Region LTO #
Biological E. Limited Private Business India N/A
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000002140826
Institution Amount Region
Biological E. Limited N/A India
Name E-Mail Phone Number Postal Address
Jennifer Olive B. Arellano jenny.arellano@novotech-cro.com +63 2 6571870 Unit A & D, 5th Floor, Rockwell Business Tower 1, Rockwell Business Center, Ortigas Avenue, Baranggay Ugong, Pasig Metro Manila 1604 Philippines
Name E-Mail Phone Number Postal Address
Dr Subhash Thuluva subhash.thuluva@biolobicale.com 91-40-7121-6000 Biological E. Limited Road No. 35, Julibee Hills Hyderabad- 500033, Telangana, India
Name Expertise Affiliation
Salvacion R. Gatchalian, MD Pediatrics Infectious Philippine General Hospital, Department of Pediatrics, Section of Infectious and Tropical Diseases
Project Location Institutional Ethics Review Board
Philippine General Hospital, Department of Pediatrics, Section of Infectious and Tropical Diseases N/A

This study requires healthy children subjects ages 16-24 months.

Safety and reactogenicity
 
To assess the safety and reactogenicity of the DTwP-rHepB-Hib-IPV vaccine when administered as a single dose in children as compared to the comparator vaccines DTwP-rHepB-Hib (ComBEfive) co-administered with IPV (Imovax Polio), in terms of solicited symptoms (local and general), unsolicited adverse events (AEs) and serious adverse events (SAEs).

Immunogenicity
 
· To describe the immune response to DTwP-rHepB-HIB-IPV vaccine as compared to the comparator vaccines DTwP-rHepB-Hib (ComBEfive) co-administered with IPV (Imovax Polio), in terms of seroprotection status and antibody GMC against diphtheria, tetanus, hepatitis B, H. influenzae type b antigens; in terms of seroprotection status and antibody GMT against polio serotypes 1, 2 and 3 and in terms of antibody GMC, vaccine response* and seropositivity rates against pertussis antigen (anti-wP) at one month after a single dose vaccination.
 
 
*Vaccine response is defined as:
 
- For initially seronegative subjects at pre-vaccination, antibody concentration ≥ seropositivity cut off one month post Dose 1
 
- For initially seropositive subjects at pre-vaccination, antibody concentration at one month post Dose 1 is ≥ 2 fold the pre-vaccination antibody concentration.  
 
IPV (Imovax Polio), in terms of solicited symptoms (local and general), unsolicited adverse events (AEs) and serious adverse events (SAEs).

Pending

  • Philippines

Clinical Trial

20180706124319

2018-08-31

None

Exclusion criteria
 
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
 
- Child in care. Please refer to the GLOSSARY OF TERMS for the definition of child in care.
 
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the administration 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ³ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
 
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), 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 vaccine/product (pharmaceutical product or device).
 
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b diseases.
 
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b diseases.
 
- 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.
 
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
 
- Major congenital defects (defined as major malformations causing significant functional or cosmetic impairment or being life‐limiting).
 
- History of any neurological disorders or seizures.
Acute disease and/or fever at the time of vaccination.
 
o Fever is defined as the endogenous elevation of at least one measured body temperature of ≥ 38◦C (≥ 100.4◦F).10
 
o Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
 
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
 
- Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period.
 
- Administration of long-acting immune-modifying drugs at any time during the study period.
 
- Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
 
- History of non-response to vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
 
- Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
 
- Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
- encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine, 
- fever ≥ 40°C (≥ 104°F) within 48 hours of vaccination not due to another identifiable cause,
- collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination, 
- convulsions with or without fever, occurring within three days of vaccination. 
- Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours of vaccination.

Interventional

BECT/HEXA/IP-050

The World Health Organization (WHO) recommends that all infants should be routinely vaccinated against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b (Hib) and measles.1,2 Despite continued gains in global vaccine coverage, WHO estimates that in 2014, 18.7 million children did not receive three doses of diphtheria-tetanus-pertussis (DTP) vaccine3, and that in 2008, 1.5 million children less than five years of age died from vaccine-preventable diseases.4
 
With the global coverage of DTP3 (three doses of DTP in infancy) now over 80%,3 incorporating additional antigens to DTP vaccines is an effective approach to integrate new vaccines into existing schedules. Combination vaccines reduce the number of injections required to complete vaccination, minimize clinic visits and reduce costs associated with vaccine transport and storage. Importantly, use of combination vaccines improves vaccination coverage rates and the timeliness of vaccination.5,6 DTP has been combined with hepatitis B surface antigen as DTwP-rHepB, which may also be mixed with Hib conjugate vaccines (DTwP-rHepB-Hib). Combinations of DTwP with Hib and inactivated poliovirus vaccine (IPV) are also available (DTwP-IPV/Hib). There is only one hexavalent vaccine that incorporates all of these antigens (DTwP-rHepB-Hib-IPV) which is currently available. 
 
Poliomyelitis is a highly infectious disease caused by any one of three poliovirus serotypes. Since the introduction of the Global Polio Eradication Initiative in 1988, the number of poliomyelitis cases has decreased from 350,000 per year in 1988, to 37 reported cases in 20163 Much of this gain is attributable to the widespread use of oral live-attenuated poliovirus vaccines (OPV), which have been the cornerstone of polio prevention in most countries since the 1960s. However, in countries where polio has already been eradicated, and in the years following global polio eradication program, the risk of vaccine-associated paralytic polio and of polio outbreaks due to circulating vaccine-derived polioviruses means that continued use of OPV is untenable. In these settings, population immunity against poliomyelitis will be maintained through the use of IPV.7 Since the production capacity of IPV for worldwide distribution is limited, reduction of the amount of IPV antigen in each vaccine dose would increase capacity and facilitate the shift from OPV to IPV.
 
The candidate fully liquid hexavalent DTwP-rHepB-Hib-IPV vaccine assessed in the present study combines the antigens of two existing vaccines: DTwP-rHepB-Hib (ComBEfive®) and IPV (Poliorix™) licensed by Biological E Ltd. (BioE) and GSK Biologicals (GSK), respectively.
 
 
 · Rationale for the study design
 
The objectives of this Phase I randomized study is to evaluate the reactogenicity, safety and immunogenicity of the combination vaccine DTwP-rHepB-Hib-IPV when administered as a single dose to healthy children of either gender between 16 and 24 months of age at vaccination compared with a control group that will receive a licensed DTwP-rHepB-Hib vaccine co-administered with a licensed IPV vaccine.
 
 
· Rationale for choice of study population
 
Since this is the first administration of a new combination of two registered vaccines in humans, age de-escalation from children to infants is to be investigated. To ensure appropriate vaccination against polio disease, only children primed with a well characterized polio vaccine will be enrolled. At a later phase, de-escalation to unprimed infants can then occur once the safety and immunogenicity in older children have been assessed in this current phase and considered clinically acceptable.

Randomized

Open Label

Unspecified

Parallel

To assess the safety and reactogenicity of the DTwP-rHepB-Hib-IPV vaccine when administered as a single dose in children as compared to the comparator vaccines DTwP-rHepB-Hib (ComBEfive) co-administered with IPV (Imovax Polio), in terms of solicited symptoms (local and general), unsolicited adverse events (AEs) and serious adverse events (SAEs).

Phase I

48

Unspecified

Unspecified

03 Dec 2018

Utilization Utilization Info
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