Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
关键词
抽象
日期
最后验证: | 01/31/2019 |
首次提交: | 04/18/2013 |
提交的预估入学人数: | 04/18/2013 |
首次发布: | 04/23/2013 |
上次提交的更新: | 02/20/2019 |
最近更新发布: | 02/24/2019 |
首次提交结果的日期: | 01/27/2019 |
首次提交质量检查结果的日期: | 02/20/2019 |
首次发布结果的日期: | 02/24/2019 |
实际学习开始日期: | 04/30/2013 |
预计主要完成日期: | 03/18/2014 |
预计完成日期: | 03/18/2014 |
状况或疾病
干预/治疗
Biological: PR5I (V1); Pediacel® (V2); PR5I (V3)
Biological: PR5I (V1); Pediacel® (V2); PR5I (V3)
Biological: PR5I (V1); Pediacel® (V2); PR5I (V3)
Biological: PR5I (V1); Pediacel® (V2); PR5I (V3)
Biological: PR5I (V1); Pediacel® (V2); PR5I (V3)
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: PR5I (V1); Pediacel® (V2); PR5I (V3) [Vaccination 1]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. [Vaccination 2]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. [Vaccination 3]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age. | Biological: PR5I (V1); Pediacel® (V2); PR5I (V3) Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Hepatitis B [HB; Recombinant DNA], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age. |
资格标准
有资格学习的年龄 | 46 Days 至 46 Days |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Healthy infant 46 to 74 days (both inclusive) - Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth - Parent(s)/legal representative able to comply with the study procedures Exclusion Criteria: - Participation in any study with an investigational compound or device since birth - History of congenital or acquired immunodeficiency - Chronic illness that could interfere with study conduct or completion - Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines - Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq® - History or maternal history of HBsAg seropositivity - Coagulation disorder that contraindicate intramuscular injection - History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s) - History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection - Receipt of immune globulin, blood or blood-derived products since birth - Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study |
结果
主要结果指标
1. Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL [Month 5 (one month after receiving Vaccination 3)]
2. Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL [Month 5 (one month after receiving Vaccination 3)]
次要成果指标
1. Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg) [Month 5 (one month after receiving Vaccination 3)]
2. Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen [Month 5 (one month after receiving Vaccination 3)]
3. Geometric Mean Concentration of Antibodies to Diphtheria Toxin [Month 5 (one month after receiving Vaccination 3)]
4. Geometric Mean Concentration of Antibodies to Tetanus Toxin [Month 5 (one month after receiving Vaccination 3)]
5. Geometric Mean Concentrations of Antibodies to Pertussis Antigens [Month 5 (one month after receiving Vaccination 3)]
6. Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3) [Month 5 (one month after receiving Vaccination 3)]
7. Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3) [Month 5 (one month after receiving Vaccination 3)]
8. Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies [Month 3 (one month after receiving Vaccination 2)]
9. Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8 [Month 3 (one month after receiving Vaccination 2)]
10. Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination [Up to Day 5 following each vaccination]
11. Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination [Up to Day 5 following each vaccination]
12. Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination [Up to Day 5 following each vaccination]
13. Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination [Up to Day 15 following each vaccination]
14. Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination [Up to Day 15 following each vaccination]
15. Number of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Up to Day 5 following each vaccination]
16. Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE) [Up to Day 15 following each vaccination]
17. Number of Participants Experiencing a Serious Adverse Event (SAE) [Up to ~6 months (at any time during the study)]