Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Single dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age |
|
| Group 2 | Experimental | Single dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age |
|
| Group 3 | Active Comparator | Two doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal group C polysaccharide conjugate vaccine | Biological | 0.5 mL dose, subcutaneous administration in right anterolateral thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with seroprotective antibody titers (rSBA titers >= 8) 1 month after completion of the primary vaccination in single-dose groups compared to the two-dose group | 1 month | |
| Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose | 6 to 9 months (from 4-6 months of age until 12-13 months of age) | |
| Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose | 1 month after booster dose (administered between 12-13 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titers (rSBA) titers one month after completion of the primary vaccination | 1 month after primary vaccination | |
| Antibody titers (rSBA titers) prior to the administration of the booster dose | Prior to booster dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Baxter BioScience Investigator, MD | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NZOZ Vitamed | Bydgoszcz | 85-021 | Poland | |||
| Wojewódzki Specjalistyczny Szpital Dziecięcy im. Sw. Ludwika w Krakowie, Poradnia Pediatryczna Szczepien dla Dzieci z Grup Wysokiego Ryzyka |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pneumococcal 13-valent conjugate vaccine | Biological | 0.5 mL dose, subcutaneous administration in right anterolateral thigh |
|
|
| Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine | Biological | 0.5 mL dose, subcutaneous administration in right anterolateral thigh |
|
|
| Antibody titers (rSBA titers)one month after the administration of the booster dose | 1 month after administration of booster dose |
| Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination | Within 3 days after vaccination |
| Frequency and severity of adverse events observed during the entire follow up period | Entire follow up period |
| Krakow |
| 31-503 |
| Poland |
| Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Oddzial Obserwacyjno-Zakazny dla Dzieci | Lodz | 91-347 | Poland |
| SP ZOZ Oddział Pediatyczny | Lubartów | 21-100 | Poland |
| Przychodnia Medycyny Wieku Rozwojowego | Poznan | 61-709 | Poland |
| NZLA Michałkowice Jarosz i partnerzy spolka lekarska | Siemianowice Śląskie | 41-103 | Poland |
| Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. | Tarnów | 33-100 | Poland |
| Szpital im. Świętej Jadwigi Śląskiej, Oddział Dziecięcy | Trzebnica | 55-100 | Poland |
| SPSK nr 1 we Wrocławiu, Klinika Pediatrii i Chorób Infekcyjnych | Wroclaw | 50-345 | Poland |
| NZOZ Zawidawie - Centrum Medyczne "Zatorska" | Wroclaw | 51-315 | Poland |
| CSISP. Centro Superior de Investigación en Salud Pública | Almassora | 12550 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Castellon | 12006 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Catarroja | 46470 | Spain |
| Hospital Universitario San Cecilio | Granada | 18012 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | L'Eliana | 46183 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Puçol | 46530 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Quart de Poblet | 46930 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Sagunto | 46500 | Spain |
| Instituto Hispalense de Pediatria | Seville | 41014 | Spain |
| Hosptial Universitario Joan XXIII de Tarragona | Tarragona | 43007 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Valencia | 46013 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Valencia | 46021 | Spain |
| CSISP. Centro Superior de Investigación en Salud Pública | Valencia | 46024 | Spain |
| Hospital Comarcal Axarquía | Vélez-Málaga | 29700 | Spain |
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D004369 | Pentetic Acid |
| D017325 | Hepatitis B Vaccines |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided