A Clinical Trial to Study how Safe, Tolerable, and the Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.

• Register: EUCTR
• Last refreshed on: 3 June 2013
• Main ID: EUCTR2010-021490-37-FI
• Date of registration: 20/01/2011
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur MSD
• Public title: A Clinical Trial to Study how Safe, Tolerable, and the Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.
• Scientific title: A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.
• Date of first enrolment: 11/03/2011
• Target sample size: 1240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021490-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, Finland, Germany

Contacts

• Name: Clinical Development Director
• Affiliation: Sanofi Pasteur MSD S.N.C.

• Name: Clinical Development Director
• Affiliation: Sanofi Pasteur MSD S.N.C.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject is a healthy infant and is = 46 days and = 74 days of age on the day of vaccination.
2. Subject’s parent(s)/legal representative understand the study procedures, alternate vaccinations available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
3. Subject’s parent(s)/legal representative are able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
4. Subject is able to attend all scheduled visits and to comply with the study procedures.
5. Subject’s parent(s)/legal representative has access to a telephone.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1240
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Subject is currently participating or has participated in a study with an investigational compound or device within 4 weeks of expected first dose of PR5I/vaccine control(s).
- Subject’s parent(s)/legal representative plans to enroll the subject in another clinical study during the present study period.
- Subject has history of congenital immunodeficiency or acquired immunodeficiency (e.g., HIV, splenomegaly).
- Prior to study entry, subject has received or is expected to receive
immunosuppressive agents (e.g., substances or treatments known to diminish immune response such as radiation therapy, antimetabolites, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxantm] intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to
interfere with the immune response).
- Subject has received 1) systemic immunomodulatory steroids (> the equivalent of 2 mg/kg total daily dose of prednisone) since birth, or 2) any dose of systemic immunomodulatory steroids within 7 days prior to entering study or 3) is expected to require systemic immunomodulatory steroids through the course of the study.
Subjects using non-systemic corticosteroids (e.g. topical, ophthalmic, inhaled) will be eligible for vaccination.
- Subject has a history of leukemia, lymphoma, malignant melanoma, or
myeloproliferative disorder.
- Subject has known or suspected hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines.
- Subject has chronic illness that could interfere with study conduct or completion.
- Subject has received any immune globulin, blood, or blood-derived products since birth.
- Subject has received a dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry.
- Subject has received previous vaccination with any acellular pertussis (DTaP) or whole cell pertussis (DTwP) based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccine, or combination thereof.
- *Subject has had a febrile illness within 24 hours prior to enrollment or a rectal temperature = 38.0°C at Visit 1.
- *Subject has been vaccinated with an inactivated or conjugated vaccine (e.g., influenza vaccine) within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment.
- Subject has coagulation disorder contraindicating intramuscular (IM) vaccination.
- Subject has clinically significant findings on review of systems (by medical history)
determined by investigator or sub-investigator to be sufficient for exclusion.
- Subject has developmental delay or neurological disorder (by medical history at study entry).
- Subject or his/her mother has a medical history of HBsAg seropositivity.
- Subject has history of measles, mumps rubella, varicella, Haemophilus influenzae
type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection.
- Subject’s parent(s)/legal representative is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
- Any contraindication to the concomitant stu

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type b and infection caused by all known subtypes of hepatitis B virus.
MedDRA version: 14.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: PT Classification code 10019731 Term: Hepatitis B System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: PT Classification code 10054131 Term: Tetanus immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.1 Level: LLT Classification code 10053386 Term: Poliomyelitis vaccine System Organ Class: 10042613 - Surgical and medical procedures

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Product Name: PR5I
Product Code: V419
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Tetanus toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 40-
INN or Proposed INN: Pertussis toxoid
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Filamentous Haemagglutinin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Pertactin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
INN or Proposed INN: Hepatitis B surface antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Inactivated Type 1 Poliovirus (Mahoney)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 29-
INN or Proposed INN: Inactivated Type 2 poliovirus (MEF-1)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 7-
INN or Proposed INN: Inactivated Type 3 poliovirus (Saukett)
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 26-
INN or Proposed INN: Hib conjugate to meningococcal outer membrane protein complex
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
INN or Proposed INN: D Toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 30-

Trade Name: Infanrix hexa
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Tetanus toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 40-
INN or Proposed INN: PERTUSSIS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
INN or Proposed INN: Filamentous Haemagglutinin
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: After the toddler dose (12 months)

Secondary Objective: 1. Evaluate the immunogenicity of ProQuad when administered concomitantly
with the toddler dose of PR5I.
2. Describe the safety profile associated with the administration of each dose of PR5I or INFANRIX hexa when given concomitantly with Prevenar 13, RotaTeq , and ProQuad .
3. Describe the fever profile from Day 1 through Day 5 after the administration of each dose and after all doses of PR5I or INFANRIX hexa when given concomitantly with Prevenar 13, RotaTeq , and ProQuad (Section 3.4 protocol for details).
4. Describe the percentage of subjects with solicited injection-site adverse events (i.e., pain, erythema, and swelling), and solicited systemic adverse events (i.e., vomiting, crying abnormal, drowsiness, appetite lost, and irritability) within 5 days after each and any doses of PR5I or INFANRIX hexa when coadministered with Prevenar 13, RotaTeq , and ProQuad .
5. Summarize the incidence of SAEs which will be collected as instructed in Section 3.4 protocol.

Main Objective: 1. To evaluate the immunogenicity of PR5I when given at 2, 3, 4, and 12 months.

2. To compare the immunogenicity response elicited by PR5I to that of
INFANRIX hexa when given at 2, 3, 4, and 12 months.

Primary end point(s): The primary endpoints for the acceptability hypothesis are vaccine-induced antibody
responses to all antigens contained in PR5I at Postdose 3 and after the Toddler dose (12 months) as listed in Table 2-2 of the protocol. Further details can be found in Section 3.5 of the protocol

The primary endpoints for non-inferiority hypothesis are vaccine-induced antibody
responses against antigens that are contained in both PR5I and the control vaccine at Postdose 3 and after Toddler Dose (12 months) as listed in Table 2-3 of the protocol.

Secondary ID(s)

2010-021490-37-BE

V419-007

Source(s) of Monetary Support

Merck and Co

Sanofi Pasteur