Table 5.
List of vaccines (lyophilized) under clinical trials
| Aim of the study | Condition | Intervention | Phase | Lyophilized details |
|---|---|---|---|---|
| To Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine | Infections, Rotavirus | Biological: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine|Biological: Lyophilized formulation of GSK's oral live attenuated HRV vaccine | Phase 3 | Lyophilized formulation of GSK's oral live attenuated HRV vaccine |
| Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) | Respiratory Disorders | Biological: GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E|Biological: Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A) | Phase 2 | Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine |
| Safety, Tolerability and Long-term Immunogenicity of Different Dose Regimens and Formulations of MV-CHIK in Healthy Volunteers | Chikungunya Virus Infection | Biological: MV-CHIK lyophilized formulation, low dose|Biological: MV-CHIK liquid frozen formulation, low dose|Biological: MV-CHIK SPS® formulation, low dose|Biological: MV-CHIK liquid frozen formulation, high dose|Other: Placebo | Phase 2 | MV-CHIK lyophilized formulation |
| Immunogenicity and Safety of Meningococcal MenABCWY Vaccine, and of rMenB+OMV NZ and MenACWY Administered Concomitantly | Meningitis, Meningococcal | Biological: MenABCWY vaccine|Biological: rMenB+OMV NZ (Bexsero) vaccine|Biological: MenACWY (Menveo) vaccine | Phase 2 | MenACWY lyophilized component |
| Safety and Immunogenicity of Clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120 Alone, With MF59 Adjuvant, and With Alum Adjuvant | HIV Infections | Biological: ALVAC-HIV (vCP2438) Biological: Bivalent Subtype C gp120/MF59|Biological: Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension|Biological: Bivalent Subtype C gp120 | Phase 1|Phase 2 | lyophilized vaccine |
| Safety of MV-CHIK in a previously epidemic area | Chikungunya | Biological: MV-CHIK|Biological: MMR-vaccine | Phase 2 | Lyophilized, life attenuated, measles vectored Chikungunya vaccine |
| Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain | Healthy | Biological: Shigella sonnei 53G | Phase 1 | Lyophilized Shigella Sonnei 53G |
| Safety and immunogenicity of the second dose of GBS Trivalent Vaccine | Bacterial Infection Due to Streptococcus, Group B | Biological: GBS Trivalent Vaccine | Phase 2 | lyophilized formulation of a GBS trivalent vaccine |
| Immune Response to Pentavalent Rotavirus Vaccine After a Supplemental Dose | Diarrhea Rotavirus | Biological: pentavalent rotavirus vaccine (PRV)|Biological: measles vaccine (MV)|Biological: yellow fever vaccine (YFV)|Biological: meningitis conjugate vaccine (PsA-TT-5μg) | Phase 4 | lyophilized measles vaccine |
| Safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine | Infections, Streptococcal|Streptococcal Infections | Biological: GBS Vaccine | Phase 2 | lyophilized formulation of GBS Trivalent Vaccine |
| To evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV | Dengue Fever | Drug: TDV Liquid Formulation 1|Drug: TDV Liquid Formulation 2|Drug: TDV IDT Lyophilized|Drug: Placebo | Phase 2 | lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate |
| Safety and Immunogenicity Evaluation of an Intramuscular Capsule-Conjugate Campylobacter Vaccine (CJCV1) | Campylobacter Infection | Biological: Capsule-Conjugate Campylobacter Vaccine (CJCV1)|Drug: Alhydrogel®, aluminum hydroxide adjuvant (alum) | Phase 1 | lyophilized CPS-CRM197 conjugate |
| Immunogenicity and safety of a booster dose of a MenABCWY vaccine | Meningococcal Disease | Biological: MenABCWY+OMV|Biological: MenABCWY+¼OMV|Biological: Placebo | Phase 2 | lyophilized MenACWY vaccine |
| Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY | Meningococcal Disease|Meningococcal Meningitis | Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine|Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine|Biological: Tdap | Phase 2 | lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine |
| Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine | Meningococcal Disease | Biological: MenACWY-CRM|Biological: DTaP-IPV/Hib|Biological: HBV|Biological: PCV|Biological: MMR | Phase 3 | lyophilized component (MenA) |
| To assess dHER2+AS15 Cancer Immunotherapeutic Given in Combination with Lapatinib to Patients With ErbB2 Overexpressing Metastatic Breast Cancer Refractory to Trastuzumab | Metastatic Breast Cancer | Biological: dHER2 + AS15 ASCI|Drug: Lapatinib | Phase 1|Phase 2 | lyophilized preparation |
| Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004) | Healthy | Biological: Comparator: V710|Biological: Comparator: placebo | Phase 1 | Lyophilized Formulation (V710-004) |
| Safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) | Dengue Fever|Dengue Hemorrhagic Fever|Dengue Shock Syndrome | Other: Placebo|Biological: T-DEN-Post-Transfection F17|Biological: T-DEN-Post-Transfection F19 | Phase 2 | Lyophilized T-DEN-Post-Transfection F17 |
| Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine | West Nile Fever | Biological: ChimeriVax-WN02 Low Dose|Biological: ChimeriVax-WN02 Medium Dose|Biological: ChimeriVax-WN02 High Dose|Biological: 0.9% Saline solution|Biological: 0.9 % NaCl solution | Phase 2 | Lyophilized ChimeriVax-WN02 West Nile Vaccine |
| Safety and Immunogenicity of WRAIR's MSP1 Candidate Malaria Vaccine (FMP1) Adjuvant in GSK Bio's AS02A vs. Rabies Vaccine | Malaria | Biological: FMP1/AS02A|Biological: Imovax Rabies Vaccine | Phase 1 | Lyophilized FMP1/AS02A |
| Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine Given Alone | Encephalitis, Japanese B | Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV)|Biological: Measles Vaccine (MV) | Phase 3 | Lyophilized live Japanese encephalitis vaccine SA 14-14-2 (LJEV) |