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This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIMâ„¢ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series.
Primary Objective:
To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIMâ„¢ on immunogenicity.
Secondary objective:
To describe the safety profile of the booster dose PENTAXIMâ„¢ in each vaccine group defined by the vaccines received during the primary series.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTacP IPV HepB PRP-T Combined Vaccine Group | Experimental | Participant will receive a booster dose of PENTAXIMâ„¢ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02. |
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| PENTAXIM™ and ENGERIX B® Vaccine Group | Active Comparator | Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV//PRP~T combined vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA). | Day 0 (Before booster vaccination) |
| Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value. | Day 30 Post-booster Vaccination |
| Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay. | Day 0 (pre-booster) and Day 30 post-booster |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Córdoba | Córdoba Province | 5000 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22157567 | Result | Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 458 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 15 February 2006 to 03 October 2006 at 1 clinical center in Argentina.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTacP-IPV-Hep B-PRP~T Group | Participants received a booster dose of PENTAXIMâ„¢ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| DTaP-IPV//PRP~T combined vaccine | Biological | 0.5 mL, Intramuscular |
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| Day 0 up to Day 30 post-booster vaccination |
| FG001 | PENTAXIM™ and ENGERIX B® Group | Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DTacP-IPV-Hep B-PRP~T Group | Participants received a booster dose of PENTAXIMâ„¢ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). |
| BG001 | PENTAXIM™ and ENGERIX B® Group | Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA). | Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population). | Posted | Number | Participants | Day 0 (Before booster vaccination) |
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| Primary | Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value. | Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population). | Posted | Number | Participants | Day 30 Post-booster Vaccination |
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| Secondary | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™ | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable. | Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, Safety Analysis Set population. | Posted | Number | Participants | Day 0 up to Day 30 post-booster vaccination |
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| Primary | Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. | Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay. | Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-booster) and Day 30 post-booster |
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Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.
The Safety Analysis Set (SafAS) was defined as the set of participants who received the booster vaccine. The analysis was based upon the number of participants for whom each safety assessment was performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DTacP-IPV-Hep B-PRP~T Group | Participants received a booster dose of PENTAXIMâ„¢ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). | 3 | 231 | 134 | 231 | ||
| EG001 | PENTAXIM™ and ENGERIX B® Group | Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311). | 1 | 223 | 137 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis Media Acute | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Febrile Convulsion | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
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| Solicited Injection Site Erythema | General disorders | MedDRA 7.1 | Systematic Assessment |
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| Solicited Injection Site Pain | General disorders | MedDRA 7.1 | Systematic Assessment |
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| Solicited Injection Site Swelling | General disorders | MedDRA 7.1 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 7.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 7.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
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| Crying | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
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Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| C426945 | Pentavac |
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| >=65 years |
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| Male |
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| Anti-Diphtheria (N = 228, 221) |
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| Anti-Tetanus (N = 229, 216) |
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| Anti-Polio 1 (N = 214, 205) |
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| Anti-Polio 2 (N = 217, 204) |
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| Anti-Polio 3 (N = 214, 203) |
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| Anti-Pertussis Toxoid (N= 216, 212) |
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| Anti-Filamentous Hemagglutinin (N = 230, 220) |
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